FDA panels vote in favor of stronger Yaz warnings

Two federal advisory panels voted earlier this month in favor of requiring Bayer AG to update warning labels on its popular birth control drug Yaz to reflect new concerns of an increased risk of blood clots.

The Dec. 8 joint meeting of the panels was sponsored by the U.S. Food and Drug Administration and held in Adelphi, Md. The meeting of the agency’s Reproductive Health Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee addressed the safety of drospirenone-containing oral contraceptives like Bayer’s Yaz and Yasmin.

Recent studies have found that drospirenone causes a greater risk of blood clots than similar ingredients used in previous types of birth control pills. Thousands of lawsuits are pending across the country alleging that Yaz, its predecessor, Yasmin, and the generic Ocella cause heart attacks, strokes and gallbladder failure.

At the meeting, the joint panel reviewed six conflicting studies regarding drospirenone’s increased risk of blood clots.

The panel voted 21-5 in favor of increased information on the potential risk of blood clots on the labeling of Bayer’s popular birth control pills, according to a press release.