Public Citizen Petitions FDA To Ban Birth Control Pills Containing Hormone Desogestrel

The consumer advocacy group Public Citizen on Tuesday released a petition calling on FDA to ban oral contraceptives containing the hormone desogestrel because studies have shown they are twice as likely to cause blood clots without boosting protection against pregnancy, USA Today reports (Rubin, USA Today, 2/7). The pills cited in the petition include Ortho-McNeil's Ortho-Cept; Watson Pharmaceuticals' Reclipsen; Organon's Desogen; Barr Pharmaceuticals' Mircette, Velivet, Kariva and Apri-28; and some generic pills, according to Reuters (Heavey, Reuters, 2/6). The petition says many studies back to 1995 indicate that oral contraceptives containing desogestrel cause about 30 blood clot cases per 100,000 users annually, compared with 15 cases per 100,000 users of other oral contraceptives annually. More than 7.5 million prescriptions for oral contraceptives containing desogestrel were filled as of last year, according to the petition. Sidney Wolfe, director of Public Citizen's health research group, said that on the pills' labels, under the heading "Risks of Taking Oral Contraceptives," there is a warning "in barely perceptible four-point type" stating that the blood-clot risk might be higher in oral contraceptives that contain desogestrel than in other low-dose oral contraceptives (USA Today, 2/7). "By banning [desogestrel-containing] oral contraceptives, the FDA will potentially save hundreds of young women a year from developing venous thrombosis and its disabling and sometimes fatal consequences," the petition said (Reuters, 2/6). Public Citizen is posting a video explaining the petition on YouTube to spread its message to younger pill users. FDA spokesperson Susan Cruzan said the agency "will carefully review the petition" (AP/San Diego Union-Tribune, 2/6). Barr in a statement responding to the petition said, "The labeling that accompanies the company's oral contraceptive products provides all the necessary warnings and precautions for the appropriate use of the products." Ortho-McNeil in a statement said, "When used as labeled, Ortho-Cept is a safe and effective birth control choice" (USA Today, 2/7).

The petition is available online.

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View drug information on Mircette.