TUESDAY, Feb. 6, 2007 (HealthDay News) -- Newer, "third-generation" birth-control pills that contain the synthetic progestin desogestrel are nearly twice as likely to cause potentially fatal blood clots than older pills and should be banned immediately, Public Citizen said Tuesday in a petition filed with the U.S. Food and Drug Administration.
"While the use of any type of combined oral contraceptive holds an increased risk of venous thrombosis (blood clots), third-generation birth-control pills double that risk without preventing pregnancy any more effectively than older pills do," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a prepared statement.
"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," Wolfe said.
FDA spokeswoman Susan Cruzan told the Associated Press that the agency would "carefully review the petition."
Public Citizen is a nonprofit consumer advocacy group based in Washington, D.C.
Labels on third-generation birth-control pills contain a warning about an increased risk of venous thrombosis. Blood clots, which typically develop in the legs, can break away and travel through the veins and block blood flow elsewhere in the body. If a blood clot lodges in the lungs, it can cause pulmonary embolism, which is often fatal.
Third-generation birth-control pills were developed in the 1980s in an attempt to create an oral contraceptive that caused fewer side effects than earlier versions. In December 1995, three independent studies concluded that third-generation pills were about twice as likely as second-generation versions to cause blood clots. Since then, more studies have confirmed that finding, according to Public Citizen.
Instead of desogestrel, second-generation birth-control pills contain norgestrel, levonorgestrel or norethindrone, Public Citizen said.
"The FDA must ensure the well-being and safety of women in the U.S. and ban third-generation oral contraceptives containing desogestrel," the Public Citizen petition stated. "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."
In addition to the petition, Public Citizen has started an online campaign, including a video on YouTube, to promote awareness about birth-control pill safety.
According to Public Citizen, third-generation birth-control pills that contain 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).
More information
The U.S. National Library of Medicine has more about oral contraceptives.
