FDA Scrutinizes Drospirenone Birth Control Blood Clot Risk

Schmidt & Clark, LLP is No Longer Taking These Cases - If you feel that you may have a potential case, we urge you to contact another law firm adequately suited to handle your case.

A number of newer, wildly successful birth control products that were marketed as having fewer side effects and the ability to fight acne are coming under close scrutiny by federal health regulators. Mounting research and numerous case studies have found that birth control formulations containing drospirenone are more likely to cause blood clots than older contraceptives whose active ingredient is levonegestrel. This increased risk is particularly alarming due to the fact that blood clots can cause heart attacks, strokes, and blockages in the lungs and blood vessels, which can be fatal.

What’s the problem?

December 5, 2011 – In response to the new data on blood clots, the U.S. Food & Drug Administration (FDA) may order new warning labels on a number of birth control products that became massively popular over the last decade.

These drugs use a fourth-generation progestin known as drospirenone, which was originally thought to reduce bloating, mood swings, and other side effects commonly reported with older contraceptives.

Since first being launched a decade ago, millions of women around the country have been prescribed drospirenone-containing birth control pills. But recent studies suggest a higher risk of blood clots in the legs and lungs of women taking these drugs compared to those taking levonegestrel. According to IMS health, the U.S. market for female contraceptives was nearly $3.5 billion in 2010.

Getting a clear handle on the blood clot risk is especially difficult because all birth control products containing hormones increase the risk of clotting. Making matters worse, clots may be caused by any number of external factors such as smoking, obesity, and family medical history.

For its part, Bayer has stated that its own studies have indicated no discernible difference in blood clot risk between its products and older generation birth control pills. But a number of independently-conducted studies have found the risk with drospirenone to be slightly higher. According to the latest FDA estimates, the risk of a blood clot with drospirenone contraceptives is 1.5 fold higher than that found with levonegestrel. This figure translates into approximately 10 in 10,000 women on the newer drug experiencing a clot, compared with 6 in 10,000 women on older forms of birth control.

“It’s a very small percentage of patients that develop these, but it’s such a serious side effect that I think doctors have to use a lot of caution,” said Dr. Jennifer Wu, of Lenox Hill Hospital in New York.

Awards & recognition