Feb 6 2007
The advocacy group Public Citizen has filed a petition with the Food and Drug Administration (FDA) demanding that the sale of some of the newer birth control pills be banned.
The group says some of them almost double the risk of life-threatening blood clots compared to older forms of birth control pills and should be taken off market.
All contraceptive pills are known to carry some risk of blood clots which are a side effect of the hormones, estrogen and progestin contained in the pill.
But according to Public Citizen many of the third-generation low-dose oral contraceptives contain desogestrel a type of progestin which is known to be a risk factor for blood clots.
As many as 7.5 million prescriptions were used by American women for third-generation oral contraceptives from November 2005 to October 2006 and a ban on the pills, say Public Citizen could save hundreds of women a year from developing venous thrombosis, or blood clots, which have disabling and sometimes fatal consequences.
Venous thrombosis usually appears in a patient's legs, but also can occur in the abdomen, arms, veins of the brain and superficial veins; they 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.
According to Public Citizen around 30 blood clots per 100,000 users, will occur compared to 15 blood clots per 100,000 users of older "second-generation" birth control pills that are equally as effective.
Combination oral contraceptives contain synthetic versions of both estrogen and progestins and 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.
The newer pills were developed in the 1980s in an attempt to create an oral contraceptive with fewer side effects.
But Public Citizen contends that after years of research showing no extra benefit for desogestrel-containing contraceptives, it is time for users to switch to older, safer birth control pills.
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, says the FDA has known since 1995 that some of the newer oral contraceptives were more dangerous but has allowed them to stay on the market for 12 years.
Studies as far back as 1995, published in The Lancet, showed the dangers associated with third-generation birth control pills and stated the 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 (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).
Public Citizen is a national, nonprofit consumer advocacy organization founded in 1971 to represent consumer interests in Congress, the executive branch and the courts.
FDA spokeswoman Susan Cruzan has said the agency will carefully review the petition.
Representatives for the makers of the pills have yet to comment.