FDA Requests Updates to Safyral Label

Washington, DCAlong with other birth control medications that are caught up in the drospirenone side effects debate is Safyral, a birth control that contains drospirenone and also includes a supplement to help increase levels of folate in women who use the birth control. Concerns about Safyral side effects, brought about because of drospirenone, have resulted in the US Food and Drug Administration (FDA) requesting an update to the contraceptive's label.

In December 2011, the FDA convened an advisory panel to look into the safety and effectiveness of birth control medications that contain drospirenone. Those include Yasmin, Yaz, Beyaz and Safyral, all made by Bayer AG; although there are some versions from generic companies. The concern is about the potential increased risk of blood clotting in women who use contraceptives that contain drospirenone.

The advisory panel was asked to determine whether the benefits of the drugs outweigh the risks. In a 15 to 11 vote, the panel found that the benefits still outweigh the risks, although it is notable that the vote only barely passed. Some critics argue that there is older birth control available to women that is just as effective as drospirenone birth control but does not carry the same serious risks.

Meanwhile, the panel voted overwhelmingly, 21 to 5, that the birth control labels should be updated to provide clearer warnings about the risk of blood clots.

The advisory panel only makes recommendations to the FDA, which then decides whether or not to follow the panel's suggestions. Before making its recommendations, the committee heard testimony by family members of young women whose deaths were allegedly caused by birth control that contains drospirenone.

Lawsuits against Bayer may shed more light on the issue of blood clots in women who use drospirenone birth control. According to The Wall Street Journal (12/09/11), among court documents that were not included in the FDA's hearing—because lawyers did not submit them in time, the FDA says—is a report prepared by David A. Kessler, former FDA commissioner, alleging that Bayer did not notify the FDA of all cases of blood clots linked to drospirenone prior to FDA approval.

The FDA will make a decision about drospirenone birth control in the coming months. Although studies disagree on whether or not drospirenone is linked to an increased risk of blood clots, a Reuters (12/08/11) article notes that according to experts on the panel, only Bayer-sponsored studies found Yasmin as safe as other oral contraceptives. An FDA review found that women who took Yasmin had approximately two times the risk of developing a venous thrombotic event or arterial thrombotic event as women on other forms of birth control, Reuters reports.