The fate of certain popular contraceptives is up in the air pending public meetings to be held December 8 and 9 by the U.S. Food and Drug Administration (FDA).
Two FDA committees will jointly hear presentations on the risks and benefits of contraceptives containing drospirenone (a synthetic progestin hormone) in combination with ethinyl estradiol (an estrogen) to determine if any federal action is needed.
Evidence against drospirenone-containing contraceptives has been mounting. Numerous studies have linked them to a higher risk of deep vein thrombosis (blood clots) compared to older contraceptive drugs. These blood clots usually form in the lower leg or thigh. If the clot travels to the lung, it is called a pulmonary embolism, a potentially fatal condition where an artery in the lung becomes blocked.
One study found drospirenone doubled a woman’s risk of blood clots. But other studies have been inconclusive, noting that the risk was no higher than other contraceptive drugs.
Drospirenone is found in Yaz, Gianvi, Loryna, Yasmin, Syeda, Zarah, Ocella, Beyaz and Safyral, as well as in the Ortho Evra patch and NuvaRing. In addition to contraception, some birth control pills containing drospirenone are approved to treat symptoms of premenstrual dysphoric disorder (PMDD), to treat moderate acne and to raise folate levels in women.
Bayer, the manufacturer of Yaz, Yasmin and other drospirenone-containing contraceptives, has been entangled in a slew of lawsuits and class-action suits citing harmful effects of the drug. In addition to blood clots, side effects can include stroke, heart attack, gallbladder disease and liver function disturbances, among others. But Bayer stands by its products, stating that risks are duly noted in product labeling and women are warned not to take these drugs if they have certain conditions.
The risk of blood clots associated with birth control pills is higher in women who are over age 35, smoke, are overweight and have a family history of blood clots. The FDA reports that the risk is highest during the first year after starting to use a combination birth control pill and when a woman resumes use of birth control pills after a break of four weeks or longer.
Earlier this year, the FDA told physicians to exercise caution in prescribing drospirenone-containing contraceptives and recommended they discuss the risks and symptoms of blood clots with prescribed patients.
If you are currently using any contraceptive containing drospirenone, do not stop taking it without first talking to your doctor. If you are unsure if your birth control pill is included in this category, ask your pharmacist. Of course, contact your doctor immediately if you experience persistent leg pain, severe chest pain or sudden shortness of breath.
