FDA Panel Backs Stronger Yaz, Yasmin Blood Clot Warnings

The labels for Yaz, Yasmin and other birth control pills made with drospirenone, a synthetic form of progestin, should bear stronger warnings about their possible potential to cause serious, life threatening blood clots, a panel of U.S. Food & Drug Administration (FDA) medical advisors recommended yesterday. The panel voted 21 to 5 in favor of changing the labels for Yaz, Yasmin and similar birth control pills, holding that current label warnings are inadequate.

According to a report in The New York Times, however, the panel did not recommend that the labels for Yaz, Yasmin and similar contraceptives warn that they are more dangerous than other birth control pills. The experts also suggested that the labels note that the evidence about blood clots is conflicting. The advisory panel also voted 15 to 11 that the benefits of the pills still outweigh their risks, the Times said.

The FDA is not legally obligated to follow the recommendations of its outside advisory panels, but it usually does so.

The vote yesterday came at the conclusion of a joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the safety of drospirenone-containing birth control pills. Earlier this week, in briefing documents prepared for the meeting, FDA staff had said evidence linking drospirenone to a higher risk of blood clots was conflicting, but could not be ruled out, and might warrant stronger labels for the drugs.

According to a report from the Associated Press, since 2009 a total of five large studies have found evidence that drospirenone birth control pills pose a higher risk of blood clots compared to those containing an older form of progestin. Most recently, an FDA-Funded study that involved 800,000 American women taking some birth control between 2001 and 2008 found that those taking pills with drospirenone were 75 percent more likely to experience clots compared to those taking other oral contraceptives. Only two large studies, both funded by the maker of Yaz and Yasmin, have failed to find a higher risk.

While the birth-control pill’s label now informs women of the conflicting studies, the language is confusing, said Elaine Morrato, an assistant professor in the University of Colorado, Denver, Department of Pediatrics, according to a report from Bloomberg News. She said the information needs to be presented in a simpler format, possibly in the form of a graphic.

As we’ve reported previously, Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG, and other makers of drospirenone birth control pills have been named in more than 10,000 lawsuits claiming Yaz and Yasmin caused young women to suffer dangerous blood clots and other serious side effects. In court documents unsealed on Monday, former FDA commissioner David Kessler accused Bayer AG, the maker of Yaz and Yasmin, of hiding evidence pointing to a higher rate of blood clots among users of Yasmin from the agency. Kessler is expected to testify as an expert witness on behalf of plaintiffs in Yaz and Yasmin lawsuits.

“Bayer violated its duties under FDA regulations and state law by selectively presenting data as to events,” Kessler said in the documents, citing studies that Bayer itself conducted.

Unfortunately, the panel of FDA advisors did not consider Kessler’s report as part of their deliberations. As we reported, the agency rejected its submission for the meeting, stating it was submitted after the November 23 deadline for all written materials.