Public Citizen Petitions FDA to Ban Third-Generation Birth Control Pills

Feb. 6, 2007 

Public Citizen Petitions FDA to Ban Third-Generation Birth Control Pills

Oral Contraceptives Containing Desogestrel Have Increased Risk of Blood Clots

WASHINGTON, D.C. – The Food and Drug Administration (FDA) should immediately ban third-generation oral contraceptives containing desogestrel because they almost double the risk of life-threatening blood clots compared to older forms of birth control pills, Public Citizen said in a petition filed today.

It is estimated that American women filled more than 7.5 million prescriptions for third-generation oral contraceptives from November 2005 to October 2006. Banning the pills could save hundreds of women a year from developing venous thrombosis, or blood clots, which have disabling and sometimes fatal consequences. Venous thrombosis typically appears in a patient’s legs, but also can occur in the abdomen, arms, veins of the brain and superficial veins. Blood clots are particularly dangerous because they can travel through the veins and block blood flow at another location, causing a condition known as venous thromboembolism. Blood clots that travel to the lungs can cause pulmonary embolism, which is often fatal.

In addition to the petition sent to the FDA, Public Citizen has initiated an online, grassroots effort to open a dialogue on the importance of safe birth control pills and the dangers of third-generation oral contraceptives. This effort includes a video on YouTube in which women explain why safe birth control is important to them and a place where people can sign on to the citizen’s petition to the FDA regarding the subject.

Combination oral contraceptives contain synthetic versions of both estrogen and progestins. The difference between second- and third-generation oral contraceptives is the progestin component. All third-generation contraceptives in the United States contain desogestrel, while second-generation contraceptives contain norgestrel, levonorgestrel or norethindrone. Third-generation birth control pills were developed in the 1980s in an unsuccessful attempt to create an oral contraceptive with fewer adverse effects than the previous versions.

“While the use of any type of combined oral contraceptive holds an increased risk of venous thrombosis, third-generation birth control pills double that risk without preventing pregnancy any more effectively than older pills do,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “Worse, the FDA has known since 1995 that these oral contraceptives were more dangerous but has allowed them to stay on the market for 12 years.”

The labels of all third-generation birth control pills contain a warning about this increased risk of venous thrombosis, an acknowledgement by the manufacturing companies of the greater risk of blood clots associated with third-generation oral contraceptives compared to the second-generation ones.

In December 1995, three independent studies showing the dangers associated with third-generation birth control pills appeared in The Lancet, concluding that these contraceptives had about twice the risk of venous thrombosis compared to second-generation pills. Many additional studies since then have confirmed this elevated risk. “The FDA must ensure the well-being and safety of women in the U.S. and ban third-generation oral contraceptives containing desogestrel,” the petition says. “Women should discuss with their doctors alternative methods of birth control, such as the second-generation oral contraceptives, and how to safely switch contraceptive methods.”

Along with Wolfe, the petition was co-authored and signed by Jay Parkinson, MD, MPH and Sylvia Park, MD, MPH, both research analysts for Public Citizen. Another signer was Frits Rosendaal, MD, of Leiden University in the Netherlands, who has published hundreds of papers and conducted ongoing studies of thrombosis, particularly in connection with oral contraceptives.

The third-generation oral contraceptives containing desogestrel are: Desogestrel and Ethinyl Estradiol (Duramed/Barr and Watson Pharmaceuticals), Desogestrel and Ethinyl (Duramed/Barr), Desogen (Organon), Velivet (Duramed), Kariva (Duramed/Barr), Mircette (Duramed/Barr), Apri-28 (Duramed/Barr), Ortho-Cept (Ortho-McNeil), Reclipsen (Watson) and Cyclessa (Organon).

To read the petition sent to the FDA, click here.

To view the Web site, click here.

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