WHICH BIRTH CONTROL PUTS WOMEN AT UNNECESSARY RISK?

February 15, 2007

The Food and Drug Administration (FDA) should immediately ban third-generation oral contraceptives (OCs) containing desogestrel because they almost double the risk of life-threatening blood clots compared to older forms of birth control pills. Public Citizen filed a petition with the FDA on February 6 requesting that they ban these drugs.

"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."

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 can be fatal.

The difference between second- and third-generation OCs is that all third-generation contraceptives in the United States contain desogestrel, while second-generation contraceptives contain norgestrel, levonorgestrel, norgestimate, 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.

Public Citizen recommends that instead of third-generation OCs, women use second-generation OCs, which provide the same protection against pregnancy but do not come with an added risk of blood clots.

"While the use of any type of combined oral contraceptive holds an increased risk of blood clots, 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 and editor of WorstPills.org. "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, the first 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 third-generation oral contraceptives containing desogestrel are:

• Desogestrel and Ethinyl Estradiol
• Desogen
• Velivet
• Kariva
• Mircette
• Apri-28
• Ortho-Cept
• Reclipsen
• Cyclessa

Women who are taking one of the drugs above should not stop suddenly. Follow a doctor's instructions for switching birth control to make sure there is not a chance of pill failure.

__________

Read the full petition.
Watch our video on third generation contraceptives.