Public Citizen, a consumer-advocacy organization based in Washington DC, filed a petition with the U.S. Food and Drug Administration (FDA) urging it to prohibit further sale of so-called “third-generation” oral contraceptives. The drugs contain the hormone desogestrel, which can nearly double the risk for venous thromboembolism in women, asserted the national nonprofit.
Venous thromboembolism has two forms: deep-vein thrombosis (DVT) and pulmonary thromboembolism (PE). DVT occurs when a clot forms deep in veins, usually in the lower extremities (legs, thighs or hip area), and is often associated with pain and swelling. When a clot partially or completely breaks free, it can travel through the bloodstream and lodge in the lungs, causing an embolism there. PE is a serious complication that can result in permanent damage to the lungs and, in some cases, death.
The group stated in its petition that there are approximately 30 cases of blood clots for every 100,000 users of third generation oral contraceptives annually compared to 15 cases per 100,000 second-generation oral contraceptive users. It contends that there is little evidence of greater clinical benefits for women who use the newer drugs.
“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 anymore 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 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).
The petition was filed on February 6, 2007. “FDA will carefully review the petition,” said Susan Cruzan, the agency’s spokesperson.
Source: The New York Times and Public Citizen press release dated February 6, 2007