Workers Comp & Injury Law Blog: Pet Food Tainted with Rat Poison

Workers Comp & Injury Law Blog: Pet Food Tainted with Rat Poison

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.

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.

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.

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



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[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.

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