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.
Showing posts with label jersey city lawyer. Show all posts
Showing posts with label jersey city lawyer. Show all posts
Friday, May 25, 2007
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.
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.
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