Confocal laser scanning microscopy (CLSM or LSCM) is a valuable tool for obtaining high resolution images and 3-D reconstructions. The key feature of confocal microscopy is its ability to produce blur-free images of thick specimens at various depths.
According to an article in Healthy For Life on Eye Infection Detection
EYE INFECTION DETECTION
If you wear contacts, your risk of getting a blinding eye infection goes up. Until recently there has been no easy way to diagnose the infection, but, a new technique is helping patients keep their eyesight.
Lori McRae used to live in darkness.
Lori McRae Had eye parasite infection
"We put black plastic over all the windows, and basically tried to shut out all light in the house."
She was in extreme pain and losing sight in one eye. She went to six different doctors before getting the correct diagnosis - a parasite called Acanthamoeba
William Mathers, M.D.
Ophthalmologist
Oregon Health & Science University
Portland, OR
"It's extremely common. There's amoeba everywhere. It's in our drinking water. It's all in the soil, and in all water."
Lori doesn't know how she got the infection. The amoeba could have been in the water when she washed her hands before putting in her contacts.
Whatever the cause, she was lucky to find doctor mathers. He uses a special microscope to look for the infection.
William Mathers, M.D.
"We can actually see the organisms in the eye, living in the eye without hurting the person at all.
The more common way to diagnose the infection is to culture the amoeba. Many doctors don't go to the trouble because the symptoms are similar to other eye infections.
Lori was treated for pink eye and herpes first. She was finally given the right medications, but it was too late for them to work.
She needed a cornea transplant to restore her sight. She says she hopes the new microscope will prevent others from having to go through what she has.
Lori McRae
"I'm very lucky to have come from that point to be where I am."
Even if she could, lori says she'll never go back to contacts.
If you're going to wear contacts, Doctor Mathers suggests disposable or daily wear lenses. He says people who wear their contacts overnight are ten times more likely to get infections.
BAGOLIE FRIEDMAN AMO CONTACT LENS SOLUTION RECALL INJURY LAWYERS
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Jersey City, New Jersey 07306
201-656-8500 phone
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Note: The above information is an opinion and does not constitute legal advice. Unless a retainer agreement has been signed, Rcky E. Bagolie and/or the Law offices of Bagolie Friedman, LLC is not your legal representative. The information contained in this electronic communication is confidential and may be a privileged attorney-client communication. It is intended only for the use of the recipient named above. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication, or any of its contents, is strictly prohibited. If you have received this communication in error, please reply to the sender and delete the original message and any copy of it from your computer or facsimile system. Thank you.
Wednesday, August 22, 2007
Wednesday, June 13, 2007
Moisture Plus Contact Lens Solution Recall Lawsuits
Advanced Medical Optics Voluntarily Recalls Complete MoisturePlus Contact Lens Solution
The U.S. Food and Drug Administration is alerting health care professionals and their patients who wear soft contact lenses about a voluntary recall of Complete MoisturePlus Multi Purpose Solution manufactured by Advanced Medical Optics of Santa Ana, Ca.
The company is taking this action as a precaution because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC).
Consumers who wear soft contact lenses should stop using the solution, discard all partially-used or unopened bottles and replace their lenses and storage container.
"We believe the company acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "FDA and CDC are working closely with the company to collect additional information and we will continue to alert consumers and advise them as more information becomes available."
Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses.
Consumers should ask their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection as early diagnosis is important for effective treatment. The symptoms of Acanthamoeba keratitis can be very similar to those of other more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing but Acanthamoeba is more difficult to treat.
It is estimated that Acanthamoeba keratitis infections occur in approximately 2 out of every 1 million contact lens users in the United States each year. However, in a multi-state investigation to evaluate a recent increase in Acanthamoeba keratitis cases, CDC determined that the risk of developing AK was at least seven times greater for those consumers who used Complete MoisturePlus solution versus those who did not. Additional information regarding the CDC results is available at the CDC website http://www.cdc.gov/mmwr/preview/mmwrhtml/mm56d526a1.htm.
"The ongoing CDC investigation is a collaborative effort," said Michael Beach, M.D., a Division of Parasitic Diseases team leader with CDC. "We are working with FDA, state, territory, university, and clinical partners in an effort to further understand whether usage or contamination of this solution led to these Acanthamoeba infections."
All contact lens users should closely adhere to the following measures to help prevent eye infections:
Remove contact lenses before any activity involving contact with water, including showering, using a hot tub, or swimming.
Wash hands with soap and water and dry them before handling contact lenses.
Clean contact lenses according to manufacturer guidelines and instructions from an eye care professional.
Use fresh cleaning or disinfecting solution each time lenses are cleaned and stored. Never reuse or top off old solution.
Never use saline solution and rewetting drops to disinfect lenses. Neither solution is an effective or approved disinfectant.
Schedule regular eye exams with your eye care professional
Wear and replace contact lenses according to the schedule prescribed by your eye care professional.
Store lenses in a proper storage case.
Storage cases should be irrigated with sterile contact lens solution (never use tap water) and left open to dry after each use.
Replace storage cases at least once every three months.
FDA and CDC want to gather information related to Acanthamoeba keratitis in contact lens users. Report adverse events related to these products to MedWatch, the FDA's voluntary reporting program: www.fda.gov/medwatch/report.htm; Phone: (800) 332-1088; Fax: (800) 332-0178; Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.
Consumers who believe they are in possession of the recalled product may call the company at 1-888-899-9183.
Additional information about Acanthamoeba infection is available from the CDC website at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm.
Have you or someone you love been suffering from a severe eye infection or have been diagnosed with Acanthamoeba keratitis, cornea damage or blindness? Trust Bagolie Friedman Injury Lawyers to fight for your rights and obtain the justice you deserve. We offer aggressive representation and free consultations.
We are personal injury and workers' compensation trial lawyers. Contact us now for a free, confidential and no risk consultation if you have questions about any type of accident, injury, disability, workers' compensation or disease claim. Whatever legal problem you have, our personal injury attorneys want to help. This resource offers information on a wide variety of personal injury case types and is intended to help injury victims find the information they need to understand their legal rights and make informed decisions. If you would like to discuss a potential case please feel free to call toll free 1-866-333-3LAW (1-866-333-3529)or submit a FREE online case review.
####
The U.S. Food and Drug Administration is alerting health care professionals and their patients who wear soft contact lenses about a voluntary recall of Complete MoisturePlus Multi Purpose Solution manufactured by Advanced Medical Optics of Santa Ana, Ca.
The company is taking this action as a precaution because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC).
Consumers who wear soft contact lenses should stop using the solution, discard all partially-used or unopened bottles and replace their lenses and storage container.
"We believe the company acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "FDA and CDC are working closely with the company to collect additional information and we will continue to alert consumers and advise them as more information becomes available."
Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses.
Consumers should ask their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection as early diagnosis is important for effective treatment. The symptoms of Acanthamoeba keratitis can be very similar to those of other more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing but Acanthamoeba is more difficult to treat.
It is estimated that Acanthamoeba keratitis infections occur in approximately 2 out of every 1 million contact lens users in the United States each year. However, in a multi-state investigation to evaluate a recent increase in Acanthamoeba keratitis cases, CDC determined that the risk of developing AK was at least seven times greater for those consumers who used Complete MoisturePlus solution versus those who did not. Additional information regarding the CDC results is available at the CDC website http://www.cdc.gov/mmwr/preview/mmwrhtml/mm56d526a1.htm.
"The ongoing CDC investigation is a collaborative effort," said Michael Beach, M.D., a Division of Parasitic Diseases team leader with CDC. "We are working with FDA, state, territory, university, and clinical partners in an effort to further understand whether usage or contamination of this solution led to these Acanthamoeba infections."
All contact lens users should closely adhere to the following measures to help prevent eye infections:
Remove contact lenses before any activity involving contact with water, including showering, using a hot tub, or swimming.
Wash hands with soap and water and dry them before handling contact lenses.
Clean contact lenses according to manufacturer guidelines and instructions from an eye care professional.
Use fresh cleaning or disinfecting solution each time lenses are cleaned and stored. Never reuse or top off old solution.
Never use saline solution and rewetting drops to disinfect lenses. Neither solution is an effective or approved disinfectant.
Schedule regular eye exams with your eye care professional
Wear and replace contact lenses according to the schedule prescribed by your eye care professional.
Store lenses in a proper storage case.
Storage cases should be irrigated with sterile contact lens solution (never use tap water) and left open to dry after each use.
Replace storage cases at least once every three months.
FDA and CDC want to gather information related to Acanthamoeba keratitis in contact lens users. Report adverse events related to these products to MedWatch, the FDA's voluntary reporting program: www.fda.gov/medwatch/report.htm; Phone: (800) 332-1088; Fax: (800) 332-0178; Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.
Consumers who believe they are in possession of the recalled product may call the company at 1-888-899-9183.
Additional information about Acanthamoeba infection is available from the CDC website at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm.
Have you or someone you love been suffering from a severe eye infection or have been diagnosed with Acanthamoeba keratitis, cornea damage or blindness? Trust Bagolie Friedman Injury Lawyers to fight for your rights and obtain the justice you deserve. We offer aggressive representation and free consultations.
We are personal injury and workers' compensation trial lawyers. Contact us now for a free, confidential and no risk consultation if you have questions about any type of accident, injury, disability, workers' compensation or disease claim. Whatever legal problem you have, our personal injury attorneys want to help. This resource offers information on a wide variety of personal injury case types and is intended to help injury victims find the information they need to understand their legal rights and make informed decisions. If you would like to discuss a potential case please feel free to call toll free 1-866-333-3LAW (1-866-333-3529)or submit a FREE online case review.
####
Friday, May 25, 2007
More Problems for Charite Artificail Disc - Lawsuits Mounting
The following story chronicals the problems that recipients of the Charite Artificial Lumbar Disc are having. Beware if your spine surgeon wants to put one in your back. Bagolie Friedman Injury Lawyers are investigating failed Charite Disc back surgery claims and offer free consultations and aggressive representation. Call toll free 1-866-333-3529 or visit our website now.
Problems Following Total Disc Replacement
03-Jan-07 -
The Journal of Bone and Joint Surgery (American). 2007;89:82-88.
doi:10.2106/JBJS.F.00432
© 2007 The Journal of Bone and Joint Surgery, Inc.
Prevalence of Heterotopic Ossification Following Total Disc Replacement
A Prospective, Randomized Study of Two Hundred and Seventy-six Patients
P. Justin Tortolani, MD1, Bryan W. Cunningham2, MMech Eng2, Paul C. McAfee, MD1, Gwen A. Holsapple, BS2 and Karen A. Adams, BS2
1 Scoliosis and Spine Center of Maryland, O'Dea Medical Arts Building, 7506 Osler Drive, Suite 104, Baltimore, MD 21204
2 Orthopaedic Research Laboratory, Union Memorial Hospital, 201 East University Parkway, Suite 781, Baltimore, MD 21218
Investigation performed at Scoliosis and Spine Center of Maryland, St. Joseph Medical Center, and the Orthopaedic Research Laboratory, Union Memorial Hospital, Baltimore, Maryland
--------------------------------------------------------------------------------
Background: Despite reports of good clinical outcomes in patients treated with lumbar and cervical disc replacements, varying degrees of heterotopic bone have been observed around these devices. The purposes of the present study were to determine the prevalence of heterotopic ossification following lumbar disc replacement and to investigate whether heterotopic ossification results in loss of motion or negatively affects clinical outcome.
Methods: All preoperative and postoperative radiographs from a completed prospective, randomized, United States Food and Drug Administration-regulated trial comparing replacement with the CHARITÉ Artificial Disc with anterior interbody arthrodesis were analyzed. In each of 276 patients treated with disc replacement, heterotopic ossification was categorized with use of a validated 5-point radiographic classification system both preoperatively and at all protocol-specified follow-up intervals to two years. The range of motion on flexion and extension radiographs made preoperatively was compared with that on radiographs made two years postoperatively, and the motion was correlated with the presence or absence of heterotopic ossification. Similarly, validated clinical outcome measures were correlated with the presence or absence of heterotopic ossification at two years.
Results: The prevalence of heterotopic ossification in the 276 consecutive patients treated with lumbar disc replacement with the CHARITÉ Artificial Disc was 4.3%. There were four cases of Class-I heterotopic ossification and eight cases of Class-II heterotopic ossification. In five of the twelve patients, heterotopic bone was visible as early as six weeks postoperatively, and eleven of the twelve patients had evidence of heterotopic ossification by three months postoperatively. The postoperative range of motion exceeded the preoperative range in all of the patients with heterotopic ossification. With the numbers available, no difference in either the range of motion or the clinical outcome at twenty-four months postoperatively was found between the patients who had and those who did not have heterotopic ossification.
Conclusions: Heterotopic ossification is infrequent in patients treated with the CHARITÉ Artificial Disc, and it does not impact the range of motion or clinical outcome.
Level of Evidence: Prognostic Level II. See Instructions to Authors for a complete description of levels of evidence.
Problems Following Total Disc Replacement
03-Jan-07 -
The Journal of Bone and Joint Surgery (American). 2007;89:82-88.
doi:10.2106/JBJS.F.00432
© 2007 The Journal of Bone and Joint Surgery, Inc.
Prevalence of Heterotopic Ossification Following Total Disc Replacement
A Prospective, Randomized Study of Two Hundred and Seventy-six Patients
P. Justin Tortolani, MD1, Bryan W. Cunningham2, MMech Eng2, Paul C. McAfee, MD1, Gwen A. Holsapple, BS2 and Karen A. Adams, BS2
1 Scoliosis and Spine Center of Maryland, O'Dea Medical Arts Building, 7506 Osler Drive, Suite 104, Baltimore, MD 21204
2 Orthopaedic Research Laboratory, Union Memorial Hospital, 201 East University Parkway, Suite 781, Baltimore, MD 21218
Investigation performed at Scoliosis and Spine Center of Maryland, St. Joseph Medical Center, and the Orthopaedic Research Laboratory, Union Memorial Hospital, Baltimore, Maryland
--------------------------------------------------------------------------------
Background: Despite reports of good clinical outcomes in patients treated with lumbar and cervical disc replacements, varying degrees of heterotopic bone have been observed around these devices. The purposes of the present study were to determine the prevalence of heterotopic ossification following lumbar disc replacement and to investigate whether heterotopic ossification results in loss of motion or negatively affects clinical outcome.
Methods: All preoperative and postoperative radiographs from a completed prospective, randomized, United States Food and Drug Administration-regulated trial comparing replacement with the CHARITÉ Artificial Disc with anterior interbody arthrodesis were analyzed. In each of 276 patients treated with disc replacement, heterotopic ossification was categorized with use of a validated 5-point radiographic classification system both preoperatively and at all protocol-specified follow-up intervals to two years. The range of motion on flexion and extension radiographs made preoperatively was compared with that on radiographs made two years postoperatively, and the motion was correlated with the presence or absence of heterotopic ossification. Similarly, validated clinical outcome measures were correlated with the presence or absence of heterotopic ossification at two years.
Results: The prevalence of heterotopic ossification in the 276 consecutive patients treated with lumbar disc replacement with the CHARITÉ Artificial Disc was 4.3%. There were four cases of Class-I heterotopic ossification and eight cases of Class-II heterotopic ossification. In five of the twelve patients, heterotopic bone was visible as early as six weeks postoperatively, and eleven of the twelve patients had evidence of heterotopic ossification by three months postoperatively. The postoperative range of motion exceeded the preoperative range in all of the patients with heterotopic ossification. With the numbers available, no difference in either the range of motion or the clinical outcome at twenty-four months postoperatively was found between the patients who had and those who did not have heterotopic ossification.
Conclusions: Heterotopic ossification is infrequent in patients treated with the CHARITÉ Artificial Disc, and it does not impact the range of motion or clinical outcome.
Level of Evidence: Prognostic Level II. See Instructions to Authors for a complete description of levels of evidence.
Saturday, March 24, 2007
Pet Food Tainted with Rat Poison
Pet food produced by Menu Foods was tainted with the rat poison aminopterin. Dogs and cats that have eaten the bad food have suffered from kidney failure and death.
Over 60 million cans and pouches of the Company's "wet pet" food, some of which was canned in New Jersey and sold in over 90 brands, have been recalled.
Contact Bagolie Friedman Injury Lawyers now to discuss your rights at no charge.
Friday, March 23, 2007
Pet Food Recall Danger
A Chicago woman sued Menu Foods on Tuesday, alleging the pet food manufacturer delayed announcing a recall of 60 million containers of dog and cat food despite knowing its products were contaminated and potentially deadly.
Dawn Majerczyk, 43, said her orange tabby, Phoenix, fell sick last week just two days after he ate a single package of Special Kitty. It is one of 95 cat and dog food brands recalled by Menu Foods of Canada. Friday's recall came two weeks after nine cats died during routine company taste tests of its products, the Food and Drug Administration said. Majerczyk said she took the 9-year-old cat to its first-ever veterinarian visit the day of the recall. The cat had lost six pounds in four days and was lethargic, dehydrated and nearly blind. She returned over the weekend to have him put down after his organs began to fail.
Her suit seeks class-action status. ``I want my vet bills and I want some compensation for what they did to my kids __ and for the company's neglect,'' Majerczyk, a medical assistant in a dermatology office. The company said it had not seen the suit and had no comment. The FDA had no comment on the company's delay in announcing the recall. The FDA so far has confirmed the deaths of 13 cats and one dog that had reportedly eaten the company's ``cuts and gravy'' style pet food. The wet food was sold throughout North America under store brands carried by Wal-Mart, Kroger, Safeway and other large retailers, as well as private labels like Iams, Nutro and Eukanuba.
FDA has sent inspectors to company plants in New Jersey and Kansas. Most complaints stem from products made at the latter factory, though both received shipments of wheat gluten, identified as a likely source of contamination, from the same supplier, said Stephen F. Sundlof, the FDA's chief veterinarian. The ingredient is a protein source used to thicken the pet food gravy. The FDA is screening pet food samples for substances known to be toxic to the kidneys, like toxins produced by molds.
A complete list of the recalled products along with product codes, descriptions and production dates was available from the Menu Foods Web site, http://www.menufoods.com/recall . The company also designated two phone numbers that pet owners could call for information __ (866) 463-6738 and (866) 895-2708. FDA inspectors had never before visited the Kansas plant. The FDA warned the company following a 2004 inspection of its New Jersey factory after it failed to flag food made for zoo cats of the risk of mad cow disease if the product were fed to cattle. Menu Foods is majority owned by Menu Foods Income Fund of Streetsville, Ontario.
Contact Bagoie Friedman Injury Lawyers now for a free consultation to discuss your rights. Call toll free 1-866-333-3529.
Dawn Majerczyk, 43, said her orange tabby, Phoenix, fell sick last week just two days after he ate a single package of Special Kitty. It is one of 95 cat and dog food brands recalled by Menu Foods of Canada. Friday's recall came two weeks after nine cats died during routine company taste tests of its products, the Food and Drug Administration said. Majerczyk said she took the 9-year-old cat to its first-ever veterinarian visit the day of the recall. The cat had lost six pounds in four days and was lethargic, dehydrated and nearly blind. She returned over the weekend to have him put down after his organs began to fail.
Her suit seeks class-action status. ``I want my vet bills and I want some compensation for what they did to my kids __ and for the company's neglect,'' Majerczyk, a medical assistant in a dermatology office. The company said it had not seen the suit and had no comment. The FDA had no comment on the company's delay in announcing the recall. The FDA so far has confirmed the deaths of 13 cats and one dog that had reportedly eaten the company's ``cuts and gravy'' style pet food. The wet food was sold throughout North America under store brands carried by Wal-Mart, Kroger, Safeway and other large retailers, as well as private labels like Iams, Nutro and Eukanuba.
FDA has sent inspectors to company plants in New Jersey and Kansas. Most complaints stem from products made at the latter factory, though both received shipments of wheat gluten, identified as a likely source of contamination, from the same supplier, said Stephen F. Sundlof, the FDA's chief veterinarian. The ingredient is a protein source used to thicken the pet food gravy. The FDA is screening pet food samples for substances known to be toxic to the kidneys, like toxins produced by molds.
A complete list of the recalled products along with product codes, descriptions and production dates was available from the Menu Foods Web site, http://www.menufoods.com/recall . The company also designated two phone numbers that pet owners could call for information __ (866) 463-6738 and (866) 895-2708. FDA inspectors had never before visited the Kansas plant. The FDA warned the company following a 2004 inspection of its New Jersey factory after it failed to flag food made for zoo cats of the risk of mad cow disease if the product were fed to cattle. Menu Foods is majority owned by Menu Foods Income Fund of Streetsville, Ontario.
Contact Bagoie Friedman Injury Lawyers now for a free consultation to discuss your rights. Call toll free 1-866-333-3529.
Wednesday, March 21, 2007
Beware Ford Electrical Switch Engine Fire Danger
Texan's death rekindles Ford switch issue
Family of retiree files suit blaming component linked with engine fires. Ford expands recall.
March 6, 2007
Detroit News
Al Gavegan Sr.'s death in a house fire last summer left family and friends in San Antonio searching for answers -- and they say the evidence leads straight to Ford Motor Co. and a faulty electrical switch. The retired government contractor was well-known as the guy who operated the time clock at high school football games and taught kids with special needs. On birthdays, he asked friends to forgo gifts in favor of teddy bears he could donate to sick children at a local hospital.
Hundreds attended his funeral after the 76-year-old died Aug. 14 in a blaze that started when a late-night fire spread from his 1994 Mercury Marquis parked in his attached garage, investigators found.
A police report listed the fire's probable cause as "an electrical malfunction in the engine compartment of the vehicle." Gavegan's family soon discovered that his Grand Marquis was one of 16 million Ford vehicles built with an electrical switch that has been linked to nearly 550 fires and about 1,500 complaints.
Since 1999, Ford has recalled 6.85 million vehicles with the switches, making it one of the largest auto safety recalls in U.S. history. On Monday, Ford again expanded the recall of vehicles with the speed control switches in question. The latest recall included 155,000 2003 model SUVs and pickup trucks. But millions of vehicles with the switch, including Gavegan's Grand Marquis, have not been recalled.
Ford spokeswoman Kristen Kinley said the company has been vigilant in recalling vehicles. "We're continually looking at our products in light of how difficult this particular recall has been."
Despite five recalls and an exhaustive federal safety investigation, Ford has been unable to put an end to switch issue. Ford faces more than 20 lawsuits around the country -- including a wrongful death lawsuit to be filed today by the Gavegan family in Bexar County Court in Texas. Kinley says it is investigating the cause of the Gavegan fire and hasn't reached any conclusions.
Ford said its decision not to recall all 16 million vehicles with the switches is based on a National Highway Traffic Safety Administration investigation and its own research that show only certain vehicles with the switches are at risk of catching fire. Ford, which initially denied that the switches were defective, says an "interaction" between faulty switches and their placement in certain vehicles is to blame, not the switches alone.
NHTSA spokesman Rae Tyson said Ford has expanded the recall "whenever it has become clear" it was necessary. "This is a problem that seems to be dependent on the age of the vehicle. It's possible that higher-than-normal failure rates didn't show up right away," Tyson said.
The switch is used to deactivate a vehicle's cruise control when a driver taps a brake pedal. Most of the suits allege fires began well after the vehicles were turned off. Ford stopped using the $21 Texas Instruments switch in 2002 after a decade of use. In 1999, the company recalled the 1992 and 1993 Mercury Grand Marquis models to replace the switch, but not the 1994 model that Gavegan drove. Ford says a specific batch of switches were to blame.
Mark Chalos, a Nashville lawyer representing the Gavegan family, contends there was no significant engineering difference between the 1993 and 1994 Grand Marquis. "These companies have known for years about the fire dangers of these switches. They have chosen not to recall affected vehicles," Chalos said Monday.
The Gavegans' suit also names Texas Instruments Inc. The company sold the division that made the switches in 2006 to Sensata Technologies. Of the 6.85 million vehicles recalled, Ford has fixed 45 percent. That's a better-than-average rate for auto safety recalls, since many owners ignore letters.
A key reason the switches are a fire hazard is that they have electricity running through them after vehicles are shut off. The fix dealers install is a fused wiring harness to prevent a fire from starting.
How switch fault began
In the late 1980s, Ford asked Texas Instruments to build a fourth-generation version of a speed control switch first introduced in the 1960s. By spring 1992, Ford asked Texas Instruments to develop a quieter switch. In May 1999, following complaints, Ford recalled 279,000 1992 and 1993 model Mercury Grand Marquis sedans -- among other vehicles that had the switch. In 2000, NHTSA began a new probe of the fires from additional vehicles. In September 2002, it upgraded its investigation to an engineering analysis that lasted 22 months. At the time, NHTSA declined to take any action because of the low incidence of fires.
In November 2004, NHTSA opened another investigation into the switches after getting 36 complaints of engine fires in Ford trucks and SUVs. Two months later, Ford recalled 740,000 F-150s, Ford Expeditions and Lincoln Navigators. Ford has argued there was no conclusive evidence the systems were malfunctioning and sparking fires until September 2005, when it recalled 3.8 million pickups and SUVs from the 1994 to 2002 model years, including the Ford F-150.
At the time, Ford told owners to immediately have their cruise control switches deactivated, even though they didn't have all of the replacement parts. In August 2006, Ford recalled another 1.2 million vehicles as NHTSA closed one of the most exhaustive defect investigations in the agency's history. NHTSA's 29-page report said fatigue failure of a brake seal allows fluid to corrode the cruise control switch when it's pointed up and catch fire. Ford recently settled a widely publicized lawsuit connected to a suspected switch fire.
Darletta Mohlis of Westgate, Iowa, was killed in a May 2005 fire that the family claims started in her 1996 Ford F-150 and spread to the house. Ford denies wrongdoing, but settled the lawsuit last October. The terms are confidential.
Fire kills beloved volunteer Al Gavegan used to fall asleep watching The Tonight Show and family members believe that's likely what happened Aug. 14 when the fire broke out just before 11 p.m. After the fire started, neighbors pounded on the windows, trying to wake Gavegan. Gavegan was an Air Force veteran who tested nuclear weapons systems as a government contractor. He was an usher at St. Mary Margaret's Catholic Church, who stuffed collection envelopes and delivered Meals on Wheels. After his four children grew up, "he kind of took of the school children in the district as his kids," says his daughter, Judy Freeman, a retired school teacher in Ohio.
He was a baseball umpire and refereed football games before moving to the press box in the late 1970s to be a timekeeper at Alamo Field. Three nights a week in the fall, he ran the 30-second play clock for the San Antonio school district. This fall, in honor of Gavegan, the district silently counted down the 30-second clock before the season's first three games. I pick up the phone and find myself dialing his number," said his daughter, Janice Scott, of San Jose, Calif. "Nobody should have to suffer and go through the shock and disbelief like this."
Vehicles recalled
• May 1999: 1992-93 Ford Crown Victoria, 1992-93 Lincoln Town Car, 1992-93 Mercury Grand Marquis
• January 2005: 2000 F-150, 2000 Ford Expedition, 2000 Lincoln Navigator, 2001 Ford F-Series Super Cab truck
• September 2005: 1994-99 and 2001-02 Ford F-150 and F-150 FD, 1997-99 and 2001-2002 Ford Expedition; 2002 Lincoln Blackwood, 1994-96 Ford Bronco
• August 2006: 1996-2002 Ford E-450, 1994-96 Ford Econoline, 2000-02 Ford Excursion, 1998 Ford Explorer, 1994-2002 F-250, 1994-2002 Ford F-550, 1998 Mercury Mountaineer
• March 2007: 2003 F-150, 2003 F250-550, 2003 Ford Excursion, 2003 Lincoln Blackwood
For more information, call 888-327-4236, or go to nhtsa.gov.
Bagolie Friedman Injury Lawyers offers free legal help to victims of swithc fires. Call toll free at 1-866-333-3529.
Family of retiree files suit blaming component linked with engine fires. Ford expands recall.
March 6, 2007
Detroit News
Al Gavegan Sr.'s death in a house fire last summer left family and friends in San Antonio searching for answers -- and they say the evidence leads straight to Ford Motor Co. and a faulty electrical switch. The retired government contractor was well-known as the guy who operated the time clock at high school football games and taught kids with special needs. On birthdays, he asked friends to forgo gifts in favor of teddy bears he could donate to sick children at a local hospital.
Hundreds attended his funeral after the 76-year-old died Aug. 14 in a blaze that started when a late-night fire spread from his 1994 Mercury Marquis parked in his attached garage, investigators found.
A police report listed the fire's probable cause as "an electrical malfunction in the engine compartment of the vehicle." Gavegan's family soon discovered that his Grand Marquis was one of 16 million Ford vehicles built with an electrical switch that has been linked to nearly 550 fires and about 1,500 complaints.
Since 1999, Ford has recalled 6.85 million vehicles with the switches, making it one of the largest auto safety recalls in U.S. history. On Monday, Ford again expanded the recall of vehicles with the speed control switches in question. The latest recall included 155,000 2003 model SUVs and pickup trucks. But millions of vehicles with the switch, including Gavegan's Grand Marquis, have not been recalled.
Ford spokeswoman Kristen Kinley said the company has been vigilant in recalling vehicles. "We're continually looking at our products in light of how difficult this particular recall has been."
Despite five recalls and an exhaustive federal safety investigation, Ford has been unable to put an end to switch issue. Ford faces more than 20 lawsuits around the country -- including a wrongful death lawsuit to be filed today by the Gavegan family in Bexar County Court in Texas. Kinley says it is investigating the cause of the Gavegan fire and hasn't reached any conclusions.
Ford said its decision not to recall all 16 million vehicles with the switches is based on a National Highway Traffic Safety Administration investigation and its own research that show only certain vehicles with the switches are at risk of catching fire. Ford, which initially denied that the switches were defective, says an "interaction" between faulty switches and their placement in certain vehicles is to blame, not the switches alone.
NHTSA spokesman Rae Tyson said Ford has expanded the recall "whenever it has become clear" it was necessary. "This is a problem that seems to be dependent on the age of the vehicle. It's possible that higher-than-normal failure rates didn't show up right away," Tyson said.
The switch is used to deactivate a vehicle's cruise control when a driver taps a brake pedal. Most of the suits allege fires began well after the vehicles were turned off. Ford stopped using the $21 Texas Instruments switch in 2002 after a decade of use. In 1999, the company recalled the 1992 and 1993 Mercury Grand Marquis models to replace the switch, but not the 1994 model that Gavegan drove. Ford says a specific batch of switches were to blame.
Mark Chalos, a Nashville lawyer representing the Gavegan family, contends there was no significant engineering difference between the 1993 and 1994 Grand Marquis. "These companies have known for years about the fire dangers of these switches. They have chosen not to recall affected vehicles," Chalos said Monday.
The Gavegans' suit also names Texas Instruments Inc. The company sold the division that made the switches in 2006 to Sensata Technologies. Of the 6.85 million vehicles recalled, Ford has fixed 45 percent. That's a better-than-average rate for auto safety recalls, since many owners ignore letters.
A key reason the switches are a fire hazard is that they have electricity running through them after vehicles are shut off. The fix dealers install is a fused wiring harness to prevent a fire from starting.
How switch fault began
In the late 1980s, Ford asked Texas Instruments to build a fourth-generation version of a speed control switch first introduced in the 1960s. By spring 1992, Ford asked Texas Instruments to develop a quieter switch. In May 1999, following complaints, Ford recalled 279,000 1992 and 1993 model Mercury Grand Marquis sedans -- among other vehicles that had the switch. In 2000, NHTSA began a new probe of the fires from additional vehicles. In September 2002, it upgraded its investigation to an engineering analysis that lasted 22 months. At the time, NHTSA declined to take any action because of the low incidence of fires.
In November 2004, NHTSA opened another investigation into the switches after getting 36 complaints of engine fires in Ford trucks and SUVs. Two months later, Ford recalled 740,000 F-150s, Ford Expeditions and Lincoln Navigators. Ford has argued there was no conclusive evidence the systems were malfunctioning and sparking fires until September 2005, when it recalled 3.8 million pickups and SUVs from the 1994 to 2002 model years, including the Ford F-150.
At the time, Ford told owners to immediately have their cruise control switches deactivated, even though they didn't have all of the replacement parts. In August 2006, Ford recalled another 1.2 million vehicles as NHTSA closed one of the most exhaustive defect investigations in the agency's history. NHTSA's 29-page report said fatigue failure of a brake seal allows fluid to corrode the cruise control switch when it's pointed up and catch fire. Ford recently settled a widely publicized lawsuit connected to a suspected switch fire.
Darletta Mohlis of Westgate, Iowa, was killed in a May 2005 fire that the family claims started in her 1996 Ford F-150 and spread to the house. Ford denies wrongdoing, but settled the lawsuit last October. The terms are confidential.
Fire kills beloved volunteer Al Gavegan used to fall asleep watching The Tonight Show and family members believe that's likely what happened Aug. 14 when the fire broke out just before 11 p.m. After the fire started, neighbors pounded on the windows, trying to wake Gavegan. Gavegan was an Air Force veteran who tested nuclear weapons systems as a government contractor. He was an usher at St. Mary Margaret's Catholic Church, who stuffed collection envelopes and delivered Meals on Wheels. After his four children grew up, "he kind of took of the school children in the district as his kids," says his daughter, Judy Freeman, a retired school teacher in Ohio.
He was a baseball umpire and refereed football games before moving to the press box in the late 1970s to be a timekeeper at Alamo Field. Three nights a week in the fall, he ran the 30-second play clock for the San Antonio school district. This fall, in honor of Gavegan, the district silently counted down the 30-second clock before the season's first three games. I pick up the phone and find myself dialing his number," said his daughter, Janice Scott, of San Jose, Calif. "Nobody should have to suffer and go through the shock and disbelief like this."
Vehicles recalled
• May 1999: 1992-93 Ford Crown Victoria, 1992-93 Lincoln Town Car, 1992-93 Mercury Grand Marquis
• January 2005: 2000 F-150, 2000 Ford Expedition, 2000 Lincoln Navigator, 2001 Ford F-Series Super Cab truck
• September 2005: 1994-99 and 2001-02 Ford F-150 and F-150 FD, 1997-99 and 2001-2002 Ford Expedition; 2002 Lincoln Blackwood, 1994-96 Ford Bronco
• August 2006: 1996-2002 Ford E-450, 1994-96 Ford Econoline, 2000-02 Ford Excursion, 1998 Ford Explorer, 1994-2002 F-250, 1994-2002 Ford F-550, 1998 Mercury Mountaineer
• March 2007: 2003 F-150, 2003 F250-550, 2003 Ford Excursion, 2003 Lincoln Blackwood
For more information, call 888-327-4236, or go to nhtsa.gov.
Bagolie Friedman Injury Lawyers offers free legal help to victims of swithc fires. Call toll free at 1-866-333-3529.
Thursday, March 01, 2007
Public Citizen Petitions FDA to Ban Some Birth Control
Petition to the FDA to Ban Third Generation Oral Contraceptives Containing Desogestrel due to Increased Risk of Venous Thrombosis (HRG Publication #1799)
February 6, 2007
Andrew Von Eschenbach, M.D., Commissioner
U.S. Food and Drug Administration
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. Von Eschenbach:
Public Citizen, representing more than 100,000 consumers nationwide, hereby petitions the Food and Drug Administration (FDA) pursuant to the Federal Food, Drug and Cosmetic Act 21 U.S.C. Section 355(e)(3), and 21 C.F.R. 10.30, to immediately ban the third generation oral contraceptives containing desogestrel due to the approximately doubled risk of venous thrombosis (30 cases for every 100,000 users per year of third generation oral contraceptives compared to 15 cases for every 100,000 users of second generation oral contraceptives) and lack of evidence of clinical benefit as compared to the second generation oral contraceptives. The third generation oral contraceptives containing desogestrel are:
Desogestrel and Ethinyl Estradiol (Duramed/Barr and Watson Pharmaceuticals)
Desogen (Organon)
Mircette (Duramed/Barr)
Velivet (Duramed)
Apri-28 (Duramed/Barr)
Kariva (Duramed/Barr)
Ortho-Cept (Ortho-McNeil)
Reclipsen (Watson)
Cyclessa (Organon)
It is estimated that women in the U.S. filled more than 7.5 million prescriptions for third generation oral contraceptives this past year (November 2005 to October 2006) (IMS, National Prescription Audit). By banning third generation oral contraceptives, the FDA will potentially save hundreds of young women a year from developing venous thrombosis and its disabling and sometimes fatal consequences.
Venous thrombosis (blood clot) most typically manifests itself in the lower extremities but can occur in the abdomen, the veins of the brain, the upper extremities, and in superficial veins of the extremities. Symptoms of venous thrombosis are pain, swelling, and redness in the affected extremity. The blood clot can travel from the site where it formed and block blood flow at another location, a phenomenon known as venous thromboembolism. The potentially lethal complication of venous thrombosis is pulmonary embolism in which the blood clot becomes dislodged from a peripheral vein and travels to the lungs where it can cause partial or total obstruction of blood flow to the lungs resulting in shortness of breath because of a loss of lung function. One study found that 2% of patients with a first-recognized episode of venous thromboembolism who were younger than 40 years, died in the hospital, most of them probably from a pulmonary embolism.[1]
In addition to a risk of a fatal pulmonary embolism, venous thrombosis contributes to significant functional disability, with an estimated one-third to over one-half of patients with venous thrombosis developing post-thrombotic syndrome, a chronic complication that consists of pain, swelling, and occasionally ulceration of the affected extremity.[2],[3],[4] Finally, the recurrence risk of venous thrombosis is high at several percent per year.[5]
Background
Combination oral contraceptives contain both estrogen and progestins. Second and third generation oral contraceptives (OCs) differ in their progestin component. Third generation OCs contain desogestrel (available in the US), or gestodene (not available in the US), while second generation OCs contain norgestrel, levonorgestrel, norgestimate[*] , or norethindrone. Third generation oral contraceptives were developed in the 1980s with a goal of producing an oral contraceptive that had less androgenic adverse effects such as hirsutism and acne typically associated with the first and second generation oral contraceptives.
The use of any combined oral contraceptives has long been associated with an increased risk of venous thrombosis. But three independent studies published in December 1995 all concluded third generation oral contraceptives had about twice the risk of venous thrombosis when compared to second generation oral contraceptives.[6],[7],[8] Numerous similar studies have found generally the same increased risk with the most common estimate of this risk being 1.5 to 2.4 -fold higher compared to second generation oral contraceptives.[9],[10],[11],[12],[13],[14],[15],[16],[17],[18],[19] The difference in venous thrombosis risk between second and third generation OCs is even higher among women who use oral contraceptives for the first time.[17]
Another alarming report came from a case-control study of fatal pulmonary embolism in New Zealand women. The increased risk of death from a pulmonary embolus for women who took levonorgestrel OCs was 5.1 to 1(compared to non pill-users), but the risk of death from a pulmonary embolus for women who took desogestrel or gestodene containing OC’s was 14.9 to 1. Our calculation for the risk of fatal pulmonary embolism comparing 3rd generation OC users with 2nd generation OC users is 2.1 (95% CI 0.45-10.15). The authors state that “the high mortality in New Zealand may partly reflect the extensive use of third-generation oral contraceptives, which seem to carry a higher risk of VTE than older contraceptives.”[20]
Accounting for possible flaws in study design and methods in previous studies, two meta-analyses in 2001 both concluded that oral contraceptives containing desogestrel increases the risk of venous thrombosis more than those OCs containing levonorgestrel (a 2nd generation OC) by a factor of 1.7.[21],[22] These studies are summarized in Table 1. The overall risk estimates from the two meta-analyses are likely to be conservative; the studies with lower risk estimates in these meta-analyses were studies sponsored by the manufacturers.[21]
Table 1. Summary of studies comparing 3rd vs. 2nd Gen. OCs and the risk of venous thrombosis
Source
Study Design
3rd vs. 2nd Gen. OCs (Estimated Relative Risk or Odds Ratio with 95% CI)
Bloemenkamp et al,[8]1995
Case-Control
2.2 (0.9-5.4)
Spitzer (Transnational),[9] 1996
Case-Control
1.5 (1.1-2.2)
Bloemankamp et al,[13] 1999
Case-Control
1.9 (0.8-4.5)
Jick et al (UK-GPRD),[14] 2000
Cohort/
Case-Control
1.9 (1.3-2.8)/
2.3 (1.3-3.9)
Farley et al (WHO),[6] 1995
Case-Control
2.4 (1.3-4.6)
Jick et al (UK-GPRD),[7] 1995
Cohort/
Case-Control
1.9 (1.1-3.2)/
2.2 (1.0-4.7)
Lidegaard et al,[12] 1998
Case-Control
1.44 (0.83-2.50)
2.19 (1.17-4.07)[a]
Andersen et al,[15] 1998
Case-Control
9.7 (0.4-259.6)[b]
Heinemann et al,[16] 2002
Case-Control
1.7 (0.9-3.6)
Farmer (UK-MediPlus),[10] 1997
Cohort/
Case-Control
1.76 (0.91-3.48)/
0.84 (0.38-1.85)
Farmer et al,[11] 1998
Case-Control
0.77 (0.38-1.57)
Herings et al,[16] 1999
Cohort
4.2 (1.7-10.2)
Farmer et al,[18] 2000
Cohort/
Case-Control
1.0 (0.6-1.6)
Lidegaard et al,[19] 2002
Case-Control
1.6 (1.0-2.4)
WHO,[23] 1995
Case-Control
1.66 (1.04-2.65)[c] (Europe)
3.42 (1.35-8.65)[c] (Developing countries)
Kemmeren et al,[21] 2001
Meta-analysis
1.7 (1.4-2.0)
Hennessy et al,[22] 2001
Meta-analysis
1.7 (1.3-2.1)
2.1 (1.6-2.8)[d]
[a] Our calculations of OR and 95% CI for 3rd gen. OCs containing desogestrel vs. 2nd gen. OCs.
[b] 3rd gen. OCs vs. 1st and 2nd gen. OCs.
[c] Our calculations of OR and 95% CI for 3rd gen. OCs vs. 2nd gen. OCs.
[d] 3rd gen. OCs containing desogestrel vs. 2nd gen. OCs.
Based on the epidemiologic evidence from these studies, including two meta-analyses, Public Citizen has concluded that third generation oral contraceptives essentially double the risk of venous thrombosis when compared to second generation oral contraceptives. The FDA acknowledged this in a statement in November 1995 stating “new studies indicate about a two-fold increase in the risk of venous blood clots associated with products containing desogestrel.” The risk essentially translates to about 1.5 additional incidents of thromboembolic disease per 10,000 women-years.
Kemmeren et al, in their meta-analysis of case-control and cohort studies assessing risk of venous thromboembolism among women using oral contraceptives before October 1995 calculated that four deaths per 1,000,000 woman-years could be prevented by switching from third to second generation oral contraceptives.[21] These lives are tragically being sacrificed for a class of drugs with double the risk of venous thrombosis and no proven superior clinical benefit when compared to safer classes of oral contraceptives with exactly the same efficacy profile.
The epidemiologic evidence that third generation oral contraceptives containing desogestrel are more prone to causing blood clots than 2nd generation oral contraceptives led to research investigating the underlying biological mechanisms.
Biological PLAUSIBILITY
Blood coagulation is a complex process of pro-coagulant proteins (they stimulate the formation of a clot) and anti-coagulant proteins that inhibit these proteins, as well as proteins that break down a clot once it has formed. Normal blood clotting depends upon a specific, delicately-balanced interaction between these classes of proteins. If one class of proteins has more activity than the other class, an abnormal state exists and a person becomes either at risk of excessive clotting (thrombosis) or excessive bleeding. It has long been known that changes in the female hormonal status seen in pregnancy, hormone replacement therapy, or oral contraceptive usage increase pro-coagulant activity in the coagulation process. Oral contraceptives affect levels of almost all of the proteins involved in the coagulation process. The progestogen found in third generation oral contraceptives, desogestrel, appears to cause resistance to one of the anti-coagulant proteins, activated Protein C (APC).[24] As compared to second generation oral contraceptives, third generation oral contraceptives significantly decrease total and free Protein S and cause a more pronounced APC resistance.[25] When APC and Protein S are not allowed to perform their natural function of inhibiting coagulation, clots tend to form more easily, thereby increasing the risk of venous thrombosis. These studies provide a biological explanation to the increased risk of venous thrombosis with third generation oral contraceptives containing desogestrel, compared to second generation OCs.
The Current Label
All of the third generation oral contraceptives contain the following warning in their product labels regarding the risk of venous thrombosis. The warning is not bolded and is under the heading “Risks of taking Oral Contraceptives.” The warning provides proof that Organon and Ortho-McNeil acknowledge this increased risk of venous thrombosis with third generation oral contraceptives.
Risk of developing blood clots:
Blood clots and blockage of blood vessels are one of the most serious side effects of taking oral contraceptives and can cause death or serious disability. In particular, a clot in the leg can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blockage of the vessel carrying blood to the lungs. The risks of these side effects may be greater with desogestrel-containing oral contraceptives, such as [brand name of drug] (desogestrel and ethinyl estradiol), than with certain other low-dose pills. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision.
3rdGEN. OCs SHOW NO CLINICAL BENEFIT COMPARED TO 2ndGEN. OCs
The FDA acknowledged the lack of any clinical benefit of third generation oral contraceptives compared to second generation oral contraceptives. The FDA sent a letter to Organon on July 28, 1999 in response to their “false and misleading” advertising for Desogen. The FDA stated that “no clinically significant differences between Desogen and other oral contraceptives have been demonstrated in adequate and well-controlled comparative studies” and “furthermore, there are no adequate and well-controlled studies that have demonstrated that the body can sense a difference between oral contraceptives.”
The FDA also wrote in this letter “claims that imply that Desogen is superior to other oral contraceptive products because it has less side effects (i.e. hirsutism [unwanted hair] or weight gain) are false or misleading because they lack adequate substantiation from well-controlled clinical trials.”
In an extensive literature review, we found no non-industry sponsored randomized controlled trials comparing supposed clinical benefits of third generation oral contraceptives to second generation contraceptives. Since there is no evidence of any superior clinical benefit, it is impossible to recommend that third generation oral contraceptives remain on the market when second generation oral contraceptives are equally effective and do not cause an increased risk of blood clots.
Lessons Learned from the British Pill Scare of 1995
The Committee on Safety of Medicines (CSM) in Britain issued a statement on October 18, 1995 based on, at the time, three unpublished studies warning that third generation oral contraceptives were associated with a higher risk of venous thromboembolism than oral contraceptives containing second generation progestogens. The CSM sent a “Dear Doctor” letter to 190,000 physicians and pharmacists along with a supplement to the press and broadcast media outlining this doubled risk. The end of the statement attempted to provide reassurance suggesting that “Women taking one of the relevant pills should, if possible, see their doctor before their current cycle ends. No one need stop taking the pill before obtaining medical advice.” Subsequently, a “pill scare” developed in Europe, spurring various regulatory agencies to react with their recommendations concerning third generation OCs, and many investigations examining the public health impact of the pill scare.
Although there was initial concern that the pill scare may have increased conception and abortion rates, closer analysis of pharmaco-epidemiologic data showed no such effects. In the United Kingdom, there was no peak in pregnancies or pregnancy terminations.[26] Most women using third generation OCs switched to another oral contraceptive,[26],[27],[28] Women in the Netherlands also simply switched from third to second generation OCs.[29] Another study from the Netherlands showed a marked decrease in the number of women prescribed third generation OCs after 1995, without any change in overall use of oral contraceptives from 1995 to 2000.[30]
Still, FDA removal of third generation OCs from the market should be accompanied by a campaign directed at consumers and with advanced warnings to doctors and pharmacists so that they are prepared to talk to their patients.
Current users of third generation OCs should be advised to speak with their doctor about safer alternatives to birth control. Second generation OCs that do not show an increased risk of blood clots compared to third generation OCs are those containing low dose estrogen and levonorgestrel, norgestrel, or norethindrone. Examples of such second generation birth control pills are generic drugs such as Levonorgestrel and Ethinyl Estradiol, Levora and Trivora. Women should be warned that if the correct procedure for switching pills is not followed, there is a risk of pill-failure.
Of note, Public Citizens lists Yasmin (ethinyl estradiol and drospirenone) and Ortho Evra patch (ethinyl estradiol and norelgestromin) as “Do Not Use” drugs. Yasmin potentially increases the blood levels of potassium, while there is evidence that Ortho Evra increases the risk of blood clots.
CONCLUSIONS
Although third generation OCs have not shown any clinically significant benefit over second generation oral contraceptives, multiple studies and two meta-analyses show third generation oral contraceptives containing desogestrel are associated with a higher risk of venous thrombosis than are the second generation oral contraceptives. Evidence exists of a biological mechanism underlying the association between desogestrel and blood clots. Venous thrombosis can lead to significant functional disability and possibly death.
Currently, the FDA gives the physician the authority to decide which type of oral contraceptive to prescribe to patients. Vandenbroucke et al, in a New England Journal of Medicine review article on oral contraceptives and the risk of venous thrombosis, state that “the ability to prescribe prudently by withholding oral contraceptives from women with known risk factors is limited by the absence, in the majority of cases, of clinically recognizable risk factors for venous thrombosis. An investigation in New Zealand of a series of deaths due to pulmonary emboli suggested that in most cases physicians could not have foreseen the risk.”[31]
The FDA must ensure the well-being and safety of women in the U.S. and ban third generation oral contraceptives containing desogestrel. Women should discuss with their doctor alternative methods of birth control, such as the second generation oral contraceptives, and how to safely switch contraceptive methods.
ENVIRONMENTAL IMPACT STATEMENT
Nothing requested in this petition will have an impact on the environment.
CERTIFICATION
We certify that, to the best of our knowledge and belief, this petition includes all information and views on which this petition relies, and that it includes representative data and information known to the petitioners which are unfavorable to the petition.
Sincerely,
Jay Parkinson, MD, MPH
Research Analyst
Sylvia Park, MD, MPH
Research Analyst
Sidney M. Wolfe, MD
Director, Public Citizen’s Health Research Group
Frits Rosendaal, MD
Professor of Clinical Epidemiology, University of Leiden
Netherlands
[*] Although norgestimate was developed after the second generation oral contraceptives and is therefore sometimes referred to as a third generation progestagen, because it is partially metabolized to a second generation progestagen and because the studies showing increased risk of third generation pills are almost exclusively limited to desogestrel or gestodene, many researchers consider it more like a second generation progestagen.
References
--------------------------------------------------------------------------------
[1]Anderson FA, et al. (1991). A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT study. Arch Intern Med, 151:933-938.
[2]Kyrle PA, Eichinger S. (2005). Deep Vein Thrombosis. Lancet, 365:1163-1174.
[3]Prandoni P, et al. (2004). Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med, 141:249-256.
[4]Brandjes DP, et al. (1997). Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis. Lancet, 340:759-762.
[5]Christiansen SC, Cannegieter SC, Koster T, Vandenbroucke JP, Rosendaal FR. (2005). Thrombophilia, clinical factors, and recurrent venous thrombotic events. JAMA, 293: 2352-2361.
[6]Farley TMM, Meirik O, Chang CL, Marmot MG, Poulter NR, for the World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception Investigators. (1995). Effect of different progestagens in low oestrogen oral contraceptives on venous thrombo-embolic disease. Lancet, 346:1582-1588.
[7]Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C. (1995). Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet, 346:1589-93.
[8]Bleomenkamp KWM, Rosendaal FR, Helmerhorts FM, Buller HR, Vandenbroucke JP. (1995). Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestogen. Lancet, 346:1593-6.
[9]Spitzer, WO. (1996). Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. Transnational Research Group on Oral Contraceptives and the Health of Young Women. BMJ, 312(7023):83-8.
[10]Farmer, R. (1997). Population-based study of risk of venous thromboembolism associated with various oral contraceptives. Lancet, 349(9045):83-8.
[11]Farmer, R. (1998). The risks of venous thromboembolic disease among German women using oral contraceptives: a database study. Contraception, 57(2):67-70.
[12]Lidegaard, O. (1998). Oral contraceptives and venous thromboembolism. A case-control study. Contraception, 57(5):291-301.
[13]Bloemenkamp KWM, Rosendaal FR, Buller HR, Helmerhorst FM, Colly LP, Vandenbroucke JP. (1999). Risk of venous thrombosis with use of current low-dose oral contraceptives is not explained by diagnostic suspicion and referral bias. Arch Intern Med, 159:65-70.
[14]Jick H, Kaye JA, Vasilakis-Scaramozza C, Jick SS. (2000). Risk of venous thromboembolism among users of third generation oral contraceptives compared with users of oral contraceptives with levonorgestrel before and after 1995: cohort and case control analysis. BMJ, 321:1190-1195.
[15]Andersen BS, Olsen J, Nielsen GL, et al. (1998). Third generation oral contraceptives and heritable thrombophilia as risk factors of non-fatal venous thromboembolism. Thromb Haemost, 79:28-31.
[16]Heinemann LAJ, Lewis MA, Assmann A, Thiel C. (2002). Case-control studies on venous thromboembolism: bias due to design? A methodological study on venous thromboembolism and steroid hormone use. Contraception, 65:207-214.
[17]Herings RMC, Urquhart J, Leufkens HGM. (1999). Venous thromboembolism among new users of different oral contraceptives [published correction appears in Lancet.1999;354:1478]. Lancet, 354:127-128.
[18]Farmer R, Lawrenson RA, Todd J-C, et al. (2000). A comparison of the risks of venous thromboembolic disease in association with different combined oral contraceptives. Br J Clin Pharmacol, 49:580-590.
[19]Lidegaard Ø, Edstrom MB, Kreiner S. (2002). Oral contraceptives and venous thromboembolism: a five-year national case-control study. Contraception, 65:187-196.
[20]Parkin L, Skegg DCG, Wilson M, Herbison GP, Paul C. (2000) Oral contraceptives and fatal pulmonary embolism. Lancet, 355:2133-2134.
[21]Kemmeren, JM. (2001). Third Generation oral contraceptives and risk of venous thrombosis: meta-analysis. BMJ, 323(7305): 131 – 139.
[22]Hennessy S, Berlin JA, Kinman JL, Margolis DJ, Marcus SM, Strom BL. (2001). Risk of venous thromboembolism from oral contraceptives containing gestodene and desogestrel versus levonorgestrel: a meta-analysis and formal sensitivity analysis. Contraception, 64:125-133.
[23]World Health Organization. (1995). Venous thromboembolic disease and combined oral contraceptives: results of international multicentre case control study. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Lancet, 346:1575–1582.
[24]Rosing, J. (2001). Oral contraceptives, thrombosis and haemostasis. European Journal of Obstetrics & Gynecology and Reproductive Biology, 95:193-197.
[25]Tans, G. (2000). A randomized cross-over study on the effects of levonorgestrel- and desogestrel-containing oral contraceptives on the anticoagulant pathways. Thromb. Heamost, 84(1):15-21.
[26]Jick SS, Vasilakis C, Jick H. (1998). Pregnancies and terminations after 1995 warning about third-generation oral contraceptives. Lancet, 351:1404-1405.
[27]Allison, C. (1996). Aftermath of the oral contraceptive scare. Br. J. Sex. Med. Nov/Dec, 13-16.
[28]Martin RM, Hilton SR, Kerry SM. (1997). The impact of the October 1995 ‘pill scare’ on oral contraceptive use in the United Kingdom: analysis of a general practice automated database. Family Practice, 14:279-284.
[29]De Vries CS, Van den Berg PB, De Jong-van den Berg LTW. (1998). Oral Contraceptive use before and after the latest pill scare in the Netherlands. Contraception, 57: 247-249.
[30]De Jong-van den Berg L, Tobi H, Bijker B, Van den Berg P. (2003). Influence of the third generation pill controversy on prescriptions for oral contraceptives among first time users: population based study. BMJ, 326: 254.
[31]Vandenbroucke JP, Rosing J, Bloemenkamp KWM, Middeldorp S, Helmerhorst FM, Bouma BN, Rosendaal FR. (2001). Oral Contraceptives and the Risk of Venous Thrombosis. N Engl J Med, 344:1527-1535
Bagolie Friedman Injury Lawyers offers aggressive representation and free consultations. Call them toll free now at 1866-333-3529.
February 6, 2007
Andrew Von Eschenbach, M.D., Commissioner
U.S. Food and Drug Administration
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. Von Eschenbach:
Public Citizen, representing more than 100,000 consumers nationwide, hereby petitions the Food and Drug Administration (FDA) pursuant to the Federal Food, Drug and Cosmetic Act 21 U.S.C. Section 355(e)(3), and 21 C.F.R. 10.30, to immediately ban the third generation oral contraceptives containing desogestrel due to the approximately doubled risk of venous thrombosis (30 cases for every 100,000 users per year of third generation oral contraceptives compared to 15 cases for every 100,000 users of second generation oral contraceptives) and lack of evidence of clinical benefit as compared to the second generation oral contraceptives. The third generation oral contraceptives containing desogestrel are:
Desogestrel and Ethinyl Estradiol (Duramed/Barr and Watson Pharmaceuticals)
Desogen (Organon)
Mircette (Duramed/Barr)
Velivet (Duramed)
Apri-28 (Duramed/Barr)
Kariva (Duramed/Barr)
Ortho-Cept (Ortho-McNeil)
Reclipsen (Watson)
Cyclessa (Organon)
It is estimated that women in the U.S. filled more than 7.5 million prescriptions for third generation oral contraceptives this past year (November 2005 to October 2006) (IMS, National Prescription Audit). By banning third generation oral contraceptives, the FDA will potentially save hundreds of young women a year from developing venous thrombosis and its disabling and sometimes fatal consequences.
Venous thrombosis (blood clot) most typically manifests itself in the lower extremities but can occur in the abdomen, the veins of the brain, the upper extremities, and in superficial veins of the extremities. Symptoms of venous thrombosis are pain, swelling, and redness in the affected extremity. The blood clot can travel from the site where it formed and block blood flow at another location, a phenomenon known as venous thromboembolism. The potentially lethal complication of venous thrombosis is pulmonary embolism in which the blood clot becomes dislodged from a peripheral vein and travels to the lungs where it can cause partial or total obstruction of blood flow to the lungs resulting in shortness of breath because of a loss of lung function. One study found that 2% of patients with a first-recognized episode of venous thromboembolism who were younger than 40 years, died in the hospital, most of them probably from a pulmonary embolism.[1]
In addition to a risk of a fatal pulmonary embolism, venous thrombosis contributes to significant functional disability, with an estimated one-third to over one-half of patients with venous thrombosis developing post-thrombotic syndrome, a chronic complication that consists of pain, swelling, and occasionally ulceration of the affected extremity.[2],[3],[4] Finally, the recurrence risk of venous thrombosis is high at several percent per year.[5]
Background
Combination oral contraceptives contain both estrogen and progestins. Second and third generation oral contraceptives (OCs) differ in their progestin component. Third generation OCs contain desogestrel (available in the US), or gestodene (not available in the US), while second generation OCs contain norgestrel, levonorgestrel, norgestimate[*] , or norethindrone. Third generation oral contraceptives were developed in the 1980s with a goal of producing an oral contraceptive that had less androgenic adverse effects such as hirsutism and acne typically associated with the first and second generation oral contraceptives.
The use of any combined oral contraceptives has long been associated with an increased risk of venous thrombosis. But three independent studies published in December 1995 all concluded third generation oral contraceptives had about twice the risk of venous thrombosis when compared to second generation oral contraceptives.[6],[7],[8] Numerous similar studies have found generally the same increased risk with the most common estimate of this risk being 1.5 to 2.4 -fold higher compared to second generation oral contraceptives.[9],[10],[11],[12],[13],[14],[15],[16],[17],[18],[19] The difference in venous thrombosis risk between second and third generation OCs is even higher among women who use oral contraceptives for the first time.[17]
Another alarming report came from a case-control study of fatal pulmonary embolism in New Zealand women. The increased risk of death from a pulmonary embolus for women who took levonorgestrel OCs was 5.1 to 1(compared to non pill-users), but the risk of death from a pulmonary embolus for women who took desogestrel or gestodene containing OC’s was 14.9 to 1. Our calculation for the risk of fatal pulmonary embolism comparing 3rd generation OC users with 2nd generation OC users is 2.1 (95% CI 0.45-10.15). The authors state that “the high mortality in New Zealand may partly reflect the extensive use of third-generation oral contraceptives, which seem to carry a higher risk of VTE than older contraceptives.”[20]
Accounting for possible flaws in study design and methods in previous studies, two meta-analyses in 2001 both concluded that oral contraceptives containing desogestrel increases the risk of venous thrombosis more than those OCs containing levonorgestrel (a 2nd generation OC) by a factor of 1.7.[21],[22] These studies are summarized in Table 1. The overall risk estimates from the two meta-analyses are likely to be conservative; the studies with lower risk estimates in these meta-analyses were studies sponsored by the manufacturers.[21]
Table 1. Summary of studies comparing 3rd vs. 2nd Gen. OCs and the risk of venous thrombosis
Source
Study Design
3rd vs. 2nd Gen. OCs (Estimated Relative Risk or Odds Ratio with 95% CI)
Bloemenkamp et al,[8]1995
Case-Control
2.2 (0.9-5.4)
Spitzer (Transnational),[9] 1996
Case-Control
1.5 (1.1-2.2)
Bloemankamp et al,[13] 1999
Case-Control
1.9 (0.8-4.5)
Jick et al (UK-GPRD),[14] 2000
Cohort/
Case-Control
1.9 (1.3-2.8)/
2.3 (1.3-3.9)
Farley et al (WHO),[6] 1995
Case-Control
2.4 (1.3-4.6)
Jick et al (UK-GPRD),[7] 1995
Cohort/
Case-Control
1.9 (1.1-3.2)/
2.2 (1.0-4.7)
Lidegaard et al,[12] 1998
Case-Control
1.44 (0.83-2.50)
2.19 (1.17-4.07)[a]
Andersen et al,[15] 1998
Case-Control
9.7 (0.4-259.6)[b]
Heinemann et al,[16] 2002
Case-Control
1.7 (0.9-3.6)
Farmer (UK-MediPlus),[10] 1997
Cohort/
Case-Control
1.76 (0.91-3.48)/
0.84 (0.38-1.85)
Farmer et al,[11] 1998
Case-Control
0.77 (0.38-1.57)
Herings et al,[16] 1999
Cohort
4.2 (1.7-10.2)
Farmer et al,[18] 2000
Cohort/
Case-Control
1.0 (0.6-1.6)
Lidegaard et al,[19] 2002
Case-Control
1.6 (1.0-2.4)
WHO,[23] 1995
Case-Control
1.66 (1.04-2.65)[c] (Europe)
3.42 (1.35-8.65)[c] (Developing countries)
Kemmeren et al,[21] 2001
Meta-analysis
1.7 (1.4-2.0)
Hennessy et al,[22] 2001
Meta-analysis
1.7 (1.3-2.1)
2.1 (1.6-2.8)[d]
[a] Our calculations of OR and 95% CI for 3rd gen. OCs containing desogestrel vs. 2nd gen. OCs.
[b] 3rd gen. OCs vs. 1st and 2nd gen. OCs.
[c] Our calculations of OR and 95% CI for 3rd gen. OCs vs. 2nd gen. OCs.
[d] 3rd gen. OCs containing desogestrel vs. 2nd gen. OCs.
Based on the epidemiologic evidence from these studies, including two meta-analyses, Public Citizen has concluded that third generation oral contraceptives essentially double the risk of venous thrombosis when compared to second generation oral contraceptives. The FDA acknowledged this in a statement in November 1995 stating “new studies indicate about a two-fold increase in the risk of venous blood clots associated with products containing desogestrel.” The risk essentially translates to about 1.5 additional incidents of thromboembolic disease per 10,000 women-years.
Kemmeren et al, in their meta-analysis of case-control and cohort studies assessing risk of venous thromboembolism among women using oral contraceptives before October 1995 calculated that four deaths per 1,000,000 woman-years could be prevented by switching from third to second generation oral contraceptives.[21] These lives are tragically being sacrificed for a class of drugs with double the risk of venous thrombosis and no proven superior clinical benefit when compared to safer classes of oral contraceptives with exactly the same efficacy profile.
The epidemiologic evidence that third generation oral contraceptives containing desogestrel are more prone to causing blood clots than 2nd generation oral contraceptives led to research investigating the underlying biological mechanisms.
Biological PLAUSIBILITY
Blood coagulation is a complex process of pro-coagulant proteins (they stimulate the formation of a clot) and anti-coagulant proteins that inhibit these proteins, as well as proteins that break down a clot once it has formed. Normal blood clotting depends upon a specific, delicately-balanced interaction between these classes of proteins. If one class of proteins has more activity than the other class, an abnormal state exists and a person becomes either at risk of excessive clotting (thrombosis) or excessive bleeding. It has long been known that changes in the female hormonal status seen in pregnancy, hormone replacement therapy, or oral contraceptive usage increase pro-coagulant activity in the coagulation process. Oral contraceptives affect levels of almost all of the proteins involved in the coagulation process. The progestogen found in third generation oral contraceptives, desogestrel, appears to cause resistance to one of the anti-coagulant proteins, activated Protein C (APC).[24] As compared to second generation oral contraceptives, third generation oral contraceptives significantly decrease total and free Protein S and cause a more pronounced APC resistance.[25] When APC and Protein S are not allowed to perform their natural function of inhibiting coagulation, clots tend to form more easily, thereby increasing the risk of venous thrombosis. These studies provide a biological explanation to the increased risk of venous thrombosis with third generation oral contraceptives containing desogestrel, compared to second generation OCs.
The Current Label
All of the third generation oral contraceptives contain the following warning in their product labels regarding the risk of venous thrombosis. The warning is not bolded and is under the heading “Risks of taking Oral Contraceptives.” The warning provides proof that Organon and Ortho-McNeil acknowledge this increased risk of venous thrombosis with third generation oral contraceptives.
Risk of developing blood clots:
Blood clots and blockage of blood vessels are one of the most serious side effects of taking oral contraceptives and can cause death or serious disability. In particular, a clot in the leg can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blockage of the vessel carrying blood to the lungs. The risks of these side effects may be greater with desogestrel-containing oral contraceptives, such as [brand name of drug] (desogestrel and ethinyl estradiol), than with certain other low-dose pills. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision.
3rdGEN. OCs SHOW NO CLINICAL BENEFIT COMPARED TO 2ndGEN. OCs
The FDA acknowledged the lack of any clinical benefit of third generation oral contraceptives compared to second generation oral contraceptives. The FDA sent a letter to Organon on July 28, 1999 in response to their “false and misleading” advertising for Desogen. The FDA stated that “no clinically significant differences between Desogen and other oral contraceptives have been demonstrated in adequate and well-controlled comparative studies” and “furthermore, there are no adequate and well-controlled studies that have demonstrated that the body can sense a difference between oral contraceptives.”
The FDA also wrote in this letter “claims that imply that Desogen is superior to other oral contraceptive products because it has less side effects (i.e. hirsutism [unwanted hair] or weight gain) are false or misleading because they lack adequate substantiation from well-controlled clinical trials.”
In an extensive literature review, we found no non-industry sponsored randomized controlled trials comparing supposed clinical benefits of third generation oral contraceptives to second generation contraceptives. Since there is no evidence of any superior clinical benefit, it is impossible to recommend that third generation oral contraceptives remain on the market when second generation oral contraceptives are equally effective and do not cause an increased risk of blood clots.
Lessons Learned from the British Pill Scare of 1995
The Committee on Safety of Medicines (CSM) in Britain issued a statement on October 18, 1995 based on, at the time, three unpublished studies warning that third generation oral contraceptives were associated with a higher risk of venous thromboembolism than oral contraceptives containing second generation progestogens. The CSM sent a “Dear Doctor” letter to 190,000 physicians and pharmacists along with a supplement to the press and broadcast media outlining this doubled risk. The end of the statement attempted to provide reassurance suggesting that “Women taking one of the relevant pills should, if possible, see their doctor before their current cycle ends. No one need stop taking the pill before obtaining medical advice.” Subsequently, a “pill scare” developed in Europe, spurring various regulatory agencies to react with their recommendations concerning third generation OCs, and many investigations examining the public health impact of the pill scare.
Although there was initial concern that the pill scare may have increased conception and abortion rates, closer analysis of pharmaco-epidemiologic data showed no such effects. In the United Kingdom, there was no peak in pregnancies or pregnancy terminations.[26] Most women using third generation OCs switched to another oral contraceptive,[26],[27],[28] Women in the Netherlands also simply switched from third to second generation OCs.[29] Another study from the Netherlands showed a marked decrease in the number of women prescribed third generation OCs after 1995, without any change in overall use of oral contraceptives from 1995 to 2000.[30]
Still, FDA removal of third generation OCs from the market should be accompanied by a campaign directed at consumers and with advanced warnings to doctors and pharmacists so that they are prepared to talk to their patients.
Current users of third generation OCs should be advised to speak with their doctor about safer alternatives to birth control. Second generation OCs that do not show an increased risk of blood clots compared to third generation OCs are those containing low dose estrogen and levonorgestrel, norgestrel, or norethindrone. Examples of such second generation birth control pills are generic drugs such as Levonorgestrel and Ethinyl Estradiol, Levora and Trivora. Women should be warned that if the correct procedure for switching pills is not followed, there is a risk of pill-failure.
Of note, Public Citizens lists Yasmin (ethinyl estradiol and drospirenone) and Ortho Evra patch (ethinyl estradiol and norelgestromin) as “Do Not Use” drugs. Yasmin potentially increases the blood levels of potassium, while there is evidence that Ortho Evra increases the risk of blood clots.
CONCLUSIONS
Although third generation OCs have not shown any clinically significant benefit over second generation oral contraceptives, multiple studies and two meta-analyses show third generation oral contraceptives containing desogestrel are associated with a higher risk of venous thrombosis than are the second generation oral contraceptives. Evidence exists of a biological mechanism underlying the association between desogestrel and blood clots. Venous thrombosis can lead to significant functional disability and possibly death.
Currently, the FDA gives the physician the authority to decide which type of oral contraceptive to prescribe to patients. Vandenbroucke et al, in a New England Journal of Medicine review article on oral contraceptives and the risk of venous thrombosis, state that “the ability to prescribe prudently by withholding oral contraceptives from women with known risk factors is limited by the absence, in the majority of cases, of clinically recognizable risk factors for venous thrombosis. An investigation in New Zealand of a series of deaths due to pulmonary emboli suggested that in most cases physicians could not have foreseen the risk.”[31]
The FDA must ensure the well-being and safety of women in the U.S. and ban third generation oral contraceptives containing desogestrel. Women should discuss with their doctor alternative methods of birth control, such as the second generation oral contraceptives, and how to safely switch contraceptive methods.
ENVIRONMENTAL IMPACT STATEMENT
Nothing requested in this petition will have an impact on the environment.
CERTIFICATION
We certify that, to the best of our knowledge and belief, this petition includes all information and views on which this petition relies, and that it includes representative data and information known to the petitioners which are unfavorable to the petition.
Sincerely,
Jay Parkinson, MD, MPH
Research Analyst
Sylvia Park, MD, MPH
Research Analyst
Sidney M. Wolfe, MD
Director, Public Citizen’s Health Research Group
Frits Rosendaal, MD
Professor of Clinical Epidemiology, University of Leiden
Netherlands
[*] Although norgestimate was developed after the second generation oral contraceptives and is therefore sometimes referred to as a third generation progestagen, because it is partially metabolized to a second generation progestagen and because the studies showing increased risk of third generation pills are almost exclusively limited to desogestrel or gestodene, many researchers consider it more like a second generation progestagen.
References
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[1]Anderson FA, et al. (1991). A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT study. Arch Intern Med, 151:933-938.
[2]Kyrle PA, Eichinger S. (2005). Deep Vein Thrombosis. Lancet, 365:1163-1174.
[3]Prandoni P, et al. (2004). Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med, 141:249-256.
[4]Brandjes DP, et al. (1997). Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis. Lancet, 340:759-762.
[5]Christiansen SC, Cannegieter SC, Koster T, Vandenbroucke JP, Rosendaal FR. (2005). Thrombophilia, clinical factors, and recurrent venous thrombotic events. JAMA, 293: 2352-2361.
[6]Farley TMM, Meirik O, Chang CL, Marmot MG, Poulter NR, for the World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception Investigators. (1995). Effect of different progestagens in low oestrogen oral contraceptives on venous thrombo-embolic disease. Lancet, 346:1582-1588.
[7]Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C. (1995). Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet, 346:1589-93.
[8]Bleomenkamp KWM, Rosendaal FR, Helmerhorts FM, Buller HR, Vandenbroucke JP. (1995). Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestogen. Lancet, 346:1593-6.
[9]Spitzer, WO. (1996). Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. Transnational Research Group on Oral Contraceptives and the Health of Young Women. BMJ, 312(7023):83-8.
[10]Farmer, R. (1997). Population-based study of risk of venous thromboembolism associated with various oral contraceptives. Lancet, 349(9045):83-8.
[11]Farmer, R. (1998). The risks of venous thromboembolic disease among German women using oral contraceptives: a database study. Contraception, 57(2):67-70.
[12]Lidegaard, O. (1998). Oral contraceptives and venous thromboembolism. A case-control study. Contraception, 57(5):291-301.
[13]Bloemenkamp KWM, Rosendaal FR, Buller HR, Helmerhorst FM, Colly LP, Vandenbroucke JP. (1999). Risk of venous thrombosis with use of current low-dose oral contraceptives is not explained by diagnostic suspicion and referral bias. Arch Intern Med, 159:65-70.
[14]Jick H, Kaye JA, Vasilakis-Scaramozza C, Jick SS. (2000). Risk of venous thromboembolism among users of third generation oral contraceptives compared with users of oral contraceptives with levonorgestrel before and after 1995: cohort and case control analysis. BMJ, 321:1190-1195.
[15]Andersen BS, Olsen J, Nielsen GL, et al. (1998). Third generation oral contraceptives and heritable thrombophilia as risk factors of non-fatal venous thromboembolism. Thromb Haemost, 79:28-31.
[16]Heinemann LAJ, Lewis MA, Assmann A, Thiel C. (2002). Case-control studies on venous thromboembolism: bias due to design? A methodological study on venous thromboembolism and steroid hormone use. Contraception, 65:207-214.
[17]Herings RMC, Urquhart J, Leufkens HGM. (1999). Venous thromboembolism among new users of different oral contraceptives [published correction appears in Lancet.1999;354:1478]. Lancet, 354:127-128.
[18]Farmer R, Lawrenson RA, Todd J-C, et al. (2000). A comparison of the risks of venous thromboembolic disease in association with different combined oral contraceptives. Br J Clin Pharmacol, 49:580-590.
[19]Lidegaard Ø, Edstrom MB, Kreiner S. (2002). Oral contraceptives and venous thromboembolism: a five-year national case-control study. Contraception, 65:187-196.
[20]Parkin L, Skegg DCG, Wilson M, Herbison GP, Paul C. (2000) Oral contraceptives and fatal pulmonary embolism. Lancet, 355:2133-2134.
[21]Kemmeren, JM. (2001). Third Generation oral contraceptives and risk of venous thrombosis: meta-analysis. BMJ, 323(7305): 131 – 139.
[22]Hennessy S, Berlin JA, Kinman JL, Margolis DJ, Marcus SM, Strom BL. (2001). Risk of venous thromboembolism from oral contraceptives containing gestodene and desogestrel versus levonorgestrel: a meta-analysis and formal sensitivity analysis. Contraception, 64:125-133.
[23]World Health Organization. (1995). Venous thromboembolic disease and combined oral contraceptives: results of international multicentre case control study. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Lancet, 346:1575–1582.
[24]Rosing, J. (2001). Oral contraceptives, thrombosis and haemostasis. European Journal of Obstetrics & Gynecology and Reproductive Biology, 95:193-197.
[25]Tans, G. (2000). A randomized cross-over study on the effects of levonorgestrel- and desogestrel-containing oral contraceptives on the anticoagulant pathways. Thromb. Heamost, 84(1):15-21.
[26]Jick SS, Vasilakis C, Jick H. (1998). Pregnancies and terminations after 1995 warning about third-generation oral contraceptives. Lancet, 351:1404-1405.
[27]Allison, C. (1996). Aftermath of the oral contraceptive scare. Br. J. Sex. Med. Nov/Dec, 13-16.
[28]Martin RM, Hilton SR, Kerry SM. (1997). The impact of the October 1995 ‘pill scare’ on oral contraceptive use in the United Kingdom: analysis of a general practice automated database. Family Practice, 14:279-284.
[29]De Vries CS, Van den Berg PB, De Jong-van den Berg LTW. (1998). Oral Contraceptive use before and after the latest pill scare in the Netherlands. Contraception, 57: 247-249.
[30]De Jong-van den Berg L, Tobi H, Bijker B, Van den Berg P. (2003). Influence of the third generation pill controversy on prescriptions for oral contraceptives among first time users: population based study. BMJ, 326: 254.
[31]Vandenbroucke JP, Rosing J, Bloemenkamp KWM, Middeldorp S, Helmerhorst FM, Bouma BN, Rosendaal FR. (2001). Oral Contraceptives and the Risk of Venous Thrombosis. N Engl J Med, 344:1527-1535
Bagolie Friedman Injury Lawyers offers aggressive representation and free consultations. Call them toll free now at 1866-333-3529.
Saturday, February 24, 2007
Beware Ortho Evra Birth Control Patch Danger
Ortho Evra® birth-control patches may cause:
Increased risk of blood clots
Increased risk of heart attacks
Increased risk of strokes
The Ortho Evra® contraceptive patch delivers increased levels of hormones to the bloodstream through the skin.
If you or a loved one have been prescribed Ortho Evra® and have had a heart attack, stroke or blood clots, contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation. Call toll free at 1-866-333-3529 now or email us at info@bagoliefriedman.com.
Increased risk of blood clots
Increased risk of heart attacks
Increased risk of strokes
The Ortho Evra® contraceptive patch delivers increased levels of hormones to the bloodstream through the skin.
The FDA says " In general, increased estrogen exposure may increase the risk of blood clots."The FDA also says "Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks."
If you or a loved one have been prescribed Ortho Evra® and have had a heart attack, stroke or blood clots, contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation. Call toll free at 1-866-333-3529 now or email us at info@bagoliefriedman.com.
Friday, February 23, 2007
School Board to Test for Vinyl Chloride
The Corona-Norco school board voted Tuesday night to test the air at two local schools for a cancer-causing chemical that has been found at Norco High.
Over the next month, new science buildings at El Cerrito Middle and Corona High will be tested to see if plastics in the building are emitting a vapor called vinyl chloride.
Low levels of the same chemical have been found at Norco High for more than a year, but officials have presumed that the gas was coming from an underground plume of pollution from a nearby toxic-waste site.
However, earlier this month soil gas tests showed no link to the underground plume, prompting state regulators to consider building materials as the potential source.
Test results at the other two schools could reveal whether Wyle or the building materials are to blame for Norco High's problems. If the schools do test positive for the chemical, the district would also have to decide how to deal with the pollution.
Board member Bill Hedrick spearheaded this week's unanimous decision to test at other schools.
There is "no safe level" of vinyl chloride, he said.
"Whether they find a small amount or a large amount, it's got to be mitigated," Hedrick said. "Unfortunately, this is such a bad player you really don't want any of it."
Hedrick said mortgage companies have been reluctant to make loans for homes in the area.
"If mortgage companies look at it and go, we have questions, how much more of an obligation do we have as a school district to ensure safety?" he said.
It is not the first time the school district has grappled with hazardous materials in the schools, said Ted Rozzi, the district's assistant superintendent for facilities.
Over the past decade, the district mitigated hazardous mold and cancer-causing formaldehyde vapor from materials used to make portable classrooms. If found elsewhere, air circulation systems could help treat the vinyl chloride gas, he said.
In the meantime, officials with California's Department of Toxic Substances Control will continue to test for a link between the contamination at Norco High and the plume from Wyle Labs, a former hazardous-testing facility across the street from the school.
As for the building materials, the potential sources are the same poly vinyl tiles, carpets and wall coverings used in the other schools and in buildings around the nation. Such materials are capable of "off-gassing" -- defined as emission through evaporation.
According to the Environmental Protection Agency, vinyl chloride is a carcinogen that chemically alters DNA in ways that could lead to the development of tumors, liver cancer, brain cancer and angiosarcoma.
The levels found so far don't pose a health threat to students but could slightly increase the risk of cancer for teachers working in the building over a period of decades, said a state toxicologist.
At least four cases of leukemia among Norco High students in recent years have raised concerns about students' health.
No such illnesses or concerns have been linked to Corona High, said Patti Anders, the school's Parent Teacher Association president.
"I think it's good that they're testing," she said. "At least this way, they can find out what's causing the problem at Norco High School."
Bagolie Friedman Injury Lawyers can help victims of vinyl chloride and PVC exposure. Contact them now, toll free at 1-866-333-3529 for a confidential and free consultation.
Over the next month, new science buildings at El Cerrito Middle and Corona High will be tested to see if plastics in the building are emitting a vapor called vinyl chloride.
Low levels of the same chemical have been found at Norco High for more than a year, but officials have presumed that the gas was coming from an underground plume of pollution from a nearby toxic-waste site.
However, earlier this month soil gas tests showed no link to the underground plume, prompting state regulators to consider building materials as the potential source.
Test results at the other two schools could reveal whether Wyle or the building materials are to blame for Norco High's problems. If the schools do test positive for the chemical, the district would also have to decide how to deal with the pollution.
Board member Bill Hedrick spearheaded this week's unanimous decision to test at other schools.
There is "no safe level" of vinyl chloride, he said.
"Whether they find a small amount or a large amount, it's got to be mitigated," Hedrick said. "Unfortunately, this is such a bad player you really don't want any of it."
Hedrick said mortgage companies have been reluctant to make loans for homes in the area.
"If mortgage companies look at it and go, we have questions, how much more of an obligation do we have as a school district to ensure safety?" he said.
It is not the first time the school district has grappled with hazardous materials in the schools, said Ted Rozzi, the district's assistant superintendent for facilities.
Over the past decade, the district mitigated hazardous mold and cancer-causing formaldehyde vapor from materials used to make portable classrooms. If found elsewhere, air circulation systems could help treat the vinyl chloride gas, he said.
In the meantime, officials with California's Department of Toxic Substances Control will continue to test for a link between the contamination at Norco High and the plume from Wyle Labs, a former hazardous-testing facility across the street from the school.
As for the building materials, the potential sources are the same poly vinyl tiles, carpets and wall coverings used in the other schools and in buildings around the nation. Such materials are capable of "off-gassing" -- defined as emission through evaporation.
According to the Environmental Protection Agency, vinyl chloride is a carcinogen that chemically alters DNA in ways that could lead to the development of tumors, liver cancer, brain cancer and angiosarcoma.
The levels found so far don't pose a health threat to students but could slightly increase the risk of cancer for teachers working in the building over a period of decades, said a state toxicologist.
At least four cases of leukemia among Norco High students in recent years have raised concerns about students' health.
No such illnesses or concerns have been linked to Corona High, said Patti Anders, the school's Parent Teacher Association president.
"I think it's good that they're testing," she said. "At least this way, they can find out what's causing the problem at Norco High School."
Bagolie Friedman Injury Lawyers can help victims of vinyl chloride and PVC exposure. Contact them now, toll free at 1-866-333-3529 for a confidential and free consultation.
Sunday, February 18, 2007
Beware of Kugel Hernia Mesh Patch Injury
Patients who have had a hernia repair that utilized a mesh patch are urged to contact their hernia surgeons or the hospital where their hernia repair surgery took place to find out if the recalled Composix® Kugel Hernia Mesh Patch was used in their hernia repair. The FDA list of recalled Composix® Kugel Hernia Mesh Patch
The FDA has advised patients who have been implanted with one of the recalled devices to seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.
Lawyers that practice in the area of defective medical devices have begun to prepare cases against Davol, the manufacturer of the recalled Bard Composix® Kugel Mesh Hernia Patch. Bagolie Friedman Injury Lawyers are investigating claims on behalf of patients who have received the recalled hernia mesh patches.
Proper testing of this device by the manufacturer would have revealed the defects with the device and saved many of these patients from multiple additional surgeries, complications and a lifetime of pain. We offer aggressive representation and free consultations and there is no fee if there is no recovery
The Composix® Kugel Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a memory recoil ring that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.
The memory recoil ring can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to numerous complications including infections, bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
Contact Bagolie Friedman Injury Lawyers now for a no risk consultation.
The FDA has advised patients who have been implanted with one of the recalled devices to seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.
Lawyers that practice in the area of defective medical devices have begun to prepare cases against Davol, the manufacturer of the recalled Bard Composix® Kugel Mesh Hernia Patch. Bagolie Friedman Injury Lawyers are investigating claims on behalf of patients who have received the recalled hernia mesh patches.
Proper testing of this device by the manufacturer would have revealed the defects with the device and saved many of these patients from multiple additional surgeries, complications and a lifetime of pain. We offer aggressive representation and free consultations and there is no fee if there is no recovery
The Composix® Kugel Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a memory recoil ring that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.
The memory recoil ring can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to numerous complications including infections, bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
Contact Bagolie Friedman Injury Lawyers now for a no risk consultation.
Saturday, February 10, 2007
Beware: The ORTHO EVRA PATCH - Whare the adverse reactions ORTHO EVRA causes?at
Blood clots and the birth control patch — Blood clots in the leg and blood clots lungs are behind the calls for a recall on the Ortho Evra patch.
Blood clots were the adverse reactions Ortho caused in the lungs of two women given the drug in clinical trials conducted before the drug was approved and in addition to many similar cases in women after the drug was marketed.
Adverse reactions ortho evra caused are now in the new warning. The FDA belatedly acknowledges the increased dangers of using ORTHO EVRA. These adverse reactions were first noted by the FDA physician who reviewed the drug before the agency approved it.
Despite the adverse ortho reactions that the FDA has now admitted -- that women who use the ORTHO EVRA birth control patch are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill, the FDA still allowed the ORTHO EVRA on the market and is unwilling to ban or recall it.
The problem is that hundreds of pharmaceutical lobbyists put pressure on the government to keep the drugs on the market.
Birth control is prescribed to young, healthy women and should be associated with the lowest possible risk of serious adverse drug reactions. There is no evidence that the ORTHO EVRA birth control patch is a superior contraceptive compared to older birth control pills.
The Associated Press used the Freedom of Information Act to obtain adverse drug reaction reports for ORTHO EVRA from the FDA. They reported that in 23 cases where death was the outcome, doctors found that 17 of the patients’ death appeared to be blood clot-related, including 12 from last year. The FDA estimates that it receives reports of only 1 in 10 to 1 in 100 of the serious adverse drug reactions that actually occur, meaning that the actual rate of adverse reactions for Ortho Evra may be much higher.
Additionally, the Associated Press looked at the reviews of clinical trial results done by FDA physicians and scientists prior to the weekly birth control patch’s approval. The results were submitted for review by drug manufacturer Ortho-McNeil in support of ORTHO EVRA.
Ortho-McNeil and the FDA medical officer reviewing ORTHO EVRA disagreed about whether or not two cases of blood clots in the lungs (pulmonary embolus/PE) in young women participating in the pre-approval clinical trials were caused by the birth control patch. The FDA medical officer wrote:
The FDA reviewer did not agree with Ortho-McNeil’s above conclusions. The two blood clot cases of pulmonary embolus/PE, a serious and potentially fatal condition, must be counted as two cases in the original group. Furthermore the FDA insisted that ORTHO EVRA’s labeling include the possible risk of fatal blood clots such as venous thromboembolism (VTE).
The FDA also expressed concern that 211 out of 3,088 women ( or 6.8 percent) in the pre-approval clinical trials gained 10 or more pounds in the trials and the contraceptive effectiveness of the ORTHO EVRA birth control patch was reduced in women weighing more than 198 pounds.
Precautions to consider before taking ORTHO EVRA:
You could be at high risk for developing certain serious diseases that can be life threatening or may cause temporary or permanent disability or death. The risks associated with using the ORTHO EVRA birth control increase significantly if you:
• Smoke
• Have high blood pressure, diabetes, or high cholesterol
• Have or have had clotting disorders, heart attack, stroke, chest pain (angina pectoris), and cancer of the breast or reproductive organs, jaundice, or malignant or benign liver tumors
Before using the ORTHO EVRA birth control patch, you must consult your doctor and pharmacist about all the prescription drugs, vitamins, and supplements you are taking:
Are you allergic to estrogens, progestins, or other medications?
Be sure to mention any of the following: Tylenol, antibiotics, anticoagulants such as blood thinners, Lipitor, cyclosporine, HIV protease inhibitors, medications for seizures, Phenobarbital, morphine, oral steroids, thyroid medications, St. John Wort, and many more. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
In our 21st century pill popping society – drug interactions can be fatal and/or could alter the effectiveness of the ORTHO EVRA birth control patch.
Why take the risk when birth control pills are a much safer option? Women should be empowered to make the right choice for their bodies and long term health goals.
If you or a loved one has experienced problems from using the Ortho Evra Birth Control Patch, contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation.
Blood clots were the adverse reactions Ortho caused in the lungs of two women given the drug in clinical trials conducted before the drug was approved and in addition to many similar cases in women after the drug was marketed.
Adverse reactions ortho evra caused are now in the new warning. The FDA belatedly acknowledges the increased dangers of using ORTHO EVRA. These adverse reactions were first noted by the FDA physician who reviewed the drug before the agency approved it.
Despite the adverse ortho reactions that the FDA has now admitted -- that women who use the ORTHO EVRA birth control patch are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill, the FDA still allowed the ORTHO EVRA on the market and is unwilling to ban or recall it.
The problem is that hundreds of pharmaceutical lobbyists put pressure on the government to keep the drugs on the market.
Birth control is prescribed to young, healthy women and should be associated with the lowest possible risk of serious adverse drug reactions. There is no evidence that the ORTHO EVRA birth control patch is a superior contraceptive compared to older birth control pills.
The Associated Press used the Freedom of Information Act to obtain adverse drug reaction reports for ORTHO EVRA from the FDA. They reported that in 23 cases where death was the outcome, doctors found that 17 of the patients’ death appeared to be blood clot-related, including 12 from last year. The FDA estimates that it receives reports of only 1 in 10 to 1 in 100 of the serious adverse drug reactions that actually occur, meaning that the actual rate of adverse reactions for Ortho Evra may be much higher.
Additionally, the Associated Press looked at the reviews of clinical trial results done by FDA physicians and scientists prior to the weekly birth control patch’s approval. The results were submitted for review by drug manufacturer Ortho-McNeil in support of ORTHO EVRA.
Ortho-McNeil and the FDA medical officer reviewing ORTHO EVRA disagreed about whether or not two cases of blood clots in the lungs (pulmonary embolus/PE) in young women participating in the pre-approval clinical trials were caused by the birth control patch. The FDA medical officer wrote:
The FDA reviewer did not agree with Ortho-McNeil’s above conclusions. The two blood clot cases of pulmonary embolus/PE, a serious and potentially fatal condition, must be counted as two cases in the original group. Furthermore the FDA insisted that ORTHO EVRA’s labeling include the possible risk of fatal blood clots such as venous thromboembolism (VTE).
The FDA also expressed concern that 211 out of 3,088 women ( or 6.8 percent) in the pre-approval clinical trials gained 10 or more pounds in the trials and the contraceptive effectiveness of the ORTHO EVRA birth control patch was reduced in women weighing more than 198 pounds.
Precautions to consider before taking ORTHO EVRA:
You could be at high risk for developing certain serious diseases that can be life threatening or may cause temporary or permanent disability or death. The risks associated with using the ORTHO EVRA birth control increase significantly if you:
• Smoke
• Have high blood pressure, diabetes, or high cholesterol
• Have or have had clotting disorders, heart attack, stroke, chest pain (angina pectoris), and cancer of the breast or reproductive organs, jaundice, or malignant or benign liver tumors
Before using the ORTHO EVRA birth control patch, you must consult your doctor and pharmacist about all the prescription drugs, vitamins, and supplements you are taking:
Are you allergic to estrogens, progestins, or other medications?
Be sure to mention any of the following: Tylenol, antibiotics, anticoagulants such as blood thinners, Lipitor, cyclosporine, HIV protease inhibitors, medications for seizures, Phenobarbital, morphine, oral steroids, thyroid medications, St. John Wort, and many more. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
In our 21st century pill popping society – drug interactions can be fatal and/or could alter the effectiveness of the ORTHO EVRA birth control patch.
Why take the risk when birth control pills are a much safer option? Women should be empowered to make the right choice for their bodies and long term health goals.
If you or a loved one has experienced problems from using the Ortho Evra Birth Control Patch, contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation.
Saturday, January 27, 2007
Beware: Permax (pergolide mesylate) 2003 Safety Letter
Source | FDA
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
Dear Health Care Professional,
During postmarketing surveillance for Permax®, a small number of individuals have been identified as developing cardiac valvulopathy involving one or more valves during Permax therapy. Based on Lilly safety data and scientific publications, the pathological assessment of valves that were surgically removed was consistent with the valvulopathy associated with carcinoid syndrome and with the use of other ergot alkaloid drugs. While a clear causal relationship between pergolide and the valvulopathy seen in these patients can not be established, given the nature of the lesions and known similar effects of other ergots, the Warnings section of the US Package Insert for Permax will be modified to reflect these reports.
In the reports made to Lilly, aortic, mitral and tricuspid valves were involved. In some cases the symptoms or manifestations of valvulopathy improved with cessation of pergolide therapy. Valve replacement was required in two patients.
It is not known whether the fibrotic valvular changes are related to retroperitoneal, pleural, and pericardial fibrosis, which are very rare but well known adverse effects seen with Permax.
Since Permax was first launched in the United States in 1989, a very limited number of cases have been reported to Lilly and to the FDA. Of the estimated 500,000 people who have been treated with pergolide since 1989, valvulopathy has been reported in less than 0.005%.
Based on these reports, the Warnings section of the US Package Insert for Permax will be modified as follows (new wording underlined):
Serous Inflammation and Fibrosis–There have been rare reports of pleuritis, pleural effusion, pleural fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves, or retroperitoneal fibrosis in patients taking pergolide. In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of pergolide. Pergolide should be used with caution in patients with a history of these conditions, particularly those patients who experienced the events while taking ergot derivatives. Patients with a history of such events should be carefully monitored clinically and with appropriate radiographic and laboratory studies while taking pergolide.
If you have additional questions regarding Permax, you may contact Amarin Pharmaceuticals, Inc., our US licensee for Permax, at 1-800-969-4877.
Sincerely,
Valerie E. Simmons, MD, FFPM
Director
Worldwide Pharmacovigilance and Epidemiology
Eli Lilly and Company
Permax® is indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson’s disease. Please see accompanying Prescribing Information. Permax is a registered trademark of Eli Lilly and Company, and is licensed exclusively in the United States to Amarin Pharmaceuticals, Inc.
Do I Have a Permax or Dostinex Lawsuit?
If you or a loved one have taken Permax or Dostinex and suffered from any of the side effects, you should contact Bagolie Friedman Injury Lawyers immediately for a free and confidential consultation.
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
Dear Health Care Professional,
During postmarketing surveillance for Permax®, a small number of individuals have been identified as developing cardiac valvulopathy involving one or more valves during Permax therapy. Based on Lilly safety data and scientific publications, the pathological assessment of valves that were surgically removed was consistent with the valvulopathy associated with carcinoid syndrome and with the use of other ergot alkaloid drugs. While a clear causal relationship between pergolide and the valvulopathy seen in these patients can not be established, given the nature of the lesions and known similar effects of other ergots, the Warnings section of the US Package Insert for Permax will be modified to reflect these reports.
In the reports made to Lilly, aortic, mitral and tricuspid valves were involved. In some cases the symptoms or manifestations of valvulopathy improved with cessation of pergolide therapy. Valve replacement was required in two patients.
It is not known whether the fibrotic valvular changes are related to retroperitoneal, pleural, and pericardial fibrosis, which are very rare but well known adverse effects seen with Permax.
Since Permax was first launched in the United States in 1989, a very limited number of cases have been reported to Lilly and to the FDA. Of the estimated 500,000 people who have been treated with pergolide since 1989, valvulopathy has been reported in less than 0.005%.
Based on these reports, the Warnings section of the US Package Insert for Permax will be modified as follows (new wording underlined):
Serous Inflammation and Fibrosis–There have been rare reports of pleuritis, pleural effusion, pleural fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves, or retroperitoneal fibrosis in patients taking pergolide. In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of pergolide. Pergolide should be used with caution in patients with a history of these conditions, particularly those patients who experienced the events while taking ergot derivatives. Patients with a history of such events should be carefully monitored clinically and with appropriate radiographic and laboratory studies while taking pergolide.
If you have additional questions regarding Permax, you may contact Amarin Pharmaceuticals, Inc., our US licensee for Permax, at 1-800-969-4877.
Sincerely,
Valerie E. Simmons, MD, FFPM
Director
Worldwide Pharmacovigilance and Epidemiology
Eli Lilly and Company
Permax® is indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson’s disease. Please see accompanying Prescribing Information. Permax is a registered trademark of Eli Lilly and Company, and is licensed exclusively in the United States to Amarin Pharmaceuticals, Inc.
Do I Have a Permax or Dostinex Lawsuit?
If you or a loved one have taken Permax or Dostinex and suffered from any of the side effects, you should contact Bagolie Friedman Injury Lawyers immediately for a free and confidential consultation.
Tuesday, January 23, 2007
Blood Thinner Medication Warfarin Linked To Brain Bleeds In Elderly
(Posted by Tom Lamb at DrugInjuryWatch.com)
The January 9, 2007 edition of the medical journal Neurology has a report concerning a new study which reveals that elderly patients using the blood-thinning medicine warfarin may be at greater risk for having a serious brain hemorrhage. Warfarin is sold under various different brand names, with one of the more popular being Coumadin.
According to a January 9, 2007 Newsday article by staff writer Jamie Talan about this Neurology article regarding the new warfarin study:
Scientists at the University of Cincinnati College of Medicine found that use of the anticoagulant medicine increased in the 1990s, and the surge in prescriptions caused a rise in the number of drug-induced intracerebral hemorrhages, especially in people over age 80.
"We've had no idea how often this was happening," said Dr. Matthew Flaherty, lead author of the study that appears in the journal Neurology. Use of the blood thinner increased after many studies showed warfarin was effective at preventing ischemic strokes in people with atrial fibrillation, an abnormal heart rhythm.
As background, ischemic strokes are caused by a blood clot that forms in the brain or travels to the brain. By contrast, intracerebral hemorrhages involve a blood vessel bursting in the brain; as such, it is commonly referred to as a brain bleed. An intracerebral brain hemorrhage is a relatively rare form of stroke, accounting for less than ten percent of total annual stroke events.
The practical effect of this news about the increased risk of brain bleeds in elderly patients using warfarin, or Coumadin, was covered in a January 8, 2007 article by HealthDay reporter Steven Reinberg:
One expert thinks that doctors need to evaluate a patient's risk of stroke versus their risk of bleeding before prescribing warfarin.
"This study demonstrates that we need to be careful when we use these therapies," said Dr. Michael B. Rothberg, an associate professor of medicine at Tufts University School of Medicine.
Not all patients with atrial fibrillation will benefit from warfarin, Rothberg added. "Not all patients with atrial fibrillation should be getting warfarin," he said. "Patients at the highest risk for stroke will benefit the most, and patients at the highest risk for bleeding will benefit the least," he said.
Rothberg noted that although warfarin is standard treatment for atrial fibrillation, not everyone with atrial fibrillation is at the same risk of stroke. "I don't think that most doctors prescribing warfarin are assessing their patient's risk of stroke and risk of bleeding, but they should be," he said.
In closing, we want to make an important point: As with all prescription medications, patients should talk to their doctors before making any decisions not to take warfarin, or Coumadin.
The January 9, 2007 edition of the medical journal Neurology has a report concerning a new study which reveals that elderly patients using the blood-thinning medicine warfarin may be at greater risk for having a serious brain hemorrhage. Warfarin is sold under various different brand names, with one of the more popular being Coumadin.
According to a January 9, 2007 Newsday article by staff writer Jamie Talan about this Neurology article regarding the new warfarin study:
Scientists at the University of Cincinnati College of Medicine found that use of the anticoagulant medicine increased in the 1990s, and the surge in prescriptions caused a rise in the number of drug-induced intracerebral hemorrhages, especially in people over age 80.
"We've had no idea how often this was happening," said Dr. Matthew Flaherty, lead author of the study that appears in the journal Neurology. Use of the blood thinner increased after many studies showed warfarin was effective at preventing ischemic strokes in people with atrial fibrillation, an abnormal heart rhythm.
As background, ischemic strokes are caused by a blood clot that forms in the brain or travels to the brain. By contrast, intracerebral hemorrhages involve a blood vessel bursting in the brain; as such, it is commonly referred to as a brain bleed. An intracerebral brain hemorrhage is a relatively rare form of stroke, accounting for less than ten percent of total annual stroke events.
The practical effect of this news about the increased risk of brain bleeds in elderly patients using warfarin, or Coumadin, was covered in a January 8, 2007 article by HealthDay reporter Steven Reinberg:
One expert thinks that doctors need to evaluate a patient's risk of stroke versus their risk of bleeding before prescribing warfarin.
"This study demonstrates that we need to be careful when we use these therapies," said Dr. Michael B. Rothberg, an associate professor of medicine at Tufts University School of Medicine.
Not all patients with atrial fibrillation will benefit from warfarin, Rothberg added. "Not all patients with atrial fibrillation should be getting warfarin," he said. "Patients at the highest risk for stroke will benefit the most, and patients at the highest risk for bleeding will benefit the least," he said.
Rothberg noted that although warfarin is standard treatment for atrial fibrillation, not everyone with atrial fibrillation is at the same risk of stroke. "I don't think that most doctors prescribing warfarin are assessing their patient's risk of stroke and risk of bleeding, but they should be," he said.
In closing, we want to make an important point: As with all prescription medications, patients should talk to their doctors before making any decisions not to take warfarin, or Coumadin.
Saturday, January 13, 2007
Bagolie Quoted in Herald News Medical Malpractice Article
Bagolie Friedman Injury Lawyers founding partner Ricky Bagolie was recently interviewed by Betsy Querna of The Herald News for an article entiltled
If you or a loved one has been hurt or has been a victim of medical mistake or malpractice, contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation.
When Medical Care Makes Things Worse.
Legal remedy
Many turn to the legal system for recourse, though it is often in vain. "If you see 100 cases, 99 turn out not to be something actionable or worth filing," says Ricky Bagolie, a malpractice lawyer who grew up in Clifton. "A bad result doesn't mean it was negligent or bad care."
Buchalla contacted a lawyer about filing a lawsuit for allegedly bad care. He was told nothing could be done because there was no proof of wrongdoing.
Santos Sanchez, 52, of Passaic, says he contacted several lawyers, but none would take his case. He was unhappy with a breast-reduction surgery earlier this year.
If you or a loved one has been hurt or has been a victim of medical mistake or malpractice, contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation.
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