Advisory Panel Recommends Beyaz Side Effects Warning

Grand Rapids, MIAn advisory panel for the US Food and Drug Administration (FDA) has recommended stronger warnings concerning Beyaz side effects and the risk of Beyaz blood clots. The panel is concerned specifically about drospirenone side effects and the link between the use of drospirenone in certain birth control and an increased risk of life-threatening blood clots.

Drospirenone is a hormone that mimics progestin and is used in certain birth control, including Beyaz, Yaz, Yasmin and Safyral. Some recent studies have suggested a link between the use of drospirenone in contraceptives and an increased risk of patients developing blood clots.

A panel convened by the FDA on December 8, 2011, voted 21 to 5 to recommend that the FDA request stronger warnings on Beyaz and other contraceptives that contain drospirenone. The panel found that the drugs do not currently carry a strong enough warning about those risks. On the issue of whether or not the benefits of the drug outweigh the risks, the panel voted 15 to 11 in favor of the drug; a close vote considering that almost one-half of those voting felt the risks outweighed the benefits.

Panel recommendations are usually followed by the FDA, but the agency is not required to implement them.

According to The Wall Street Journal (12/09/11), panelists heard testimony by the family members of young women—some only 18 years of age—whose deaths were allegedly linked to the use of drospirenone. Lawsuits have been filed against Bayer, alleging the contraceptives caused the deaths and injury of young women.

One study, funded by the FDA, found that drospirenone-containing birth control was associated with approximately a 75 percent greater risk of blood clots than was found with other birth control pills.

Bayer Healthcare reportedly presented studies at the FDA panel meeting that did not find a greater incidence of blood clots in women who used Yaz, Yasmin or Beyaz, according to the Boston Globe (12/09/11), but some studies presented to the panel reportedly showed double the risk of blood clots. In all, the absolute risk of blood clots associated with the contraceptives is still low, but that increased risk may be unacceptable for women who would prefer to use contraceptives that are just as effective but do not carry the same risk of blood clots.