FDA Adds Stronger Warning to Yasmin and Yaz Blood Clots Label
In April 2012, the FDA unveiled the new, stronger warnings about Yasmin and Yaz blood clots that will be added to the contraceptives’ labels. Yasmin and Yaz, which are manufactured by Bayer, contain drospirenone, a synthetic progestin which some studies have known to increase the risk of blood clots.
In announcing the new warnings, the FDA stated, “The revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products…whereas other epidemiological studies found no additional risk.”
FDA Updates Yaz side effects warnings
The FDA panel voted in December to keep Yasmin and Yaz on the market, but to add new warnings. The decision to strengthen the warnings was made in December 2011, when a 26-member FDA advisory panel examined the evidence of Yaz blood clots, heard testimony, and debated the issue.
The panel ultimately voted 15 to 11 in favor of keeping the drospirenone-containing contraceptives on the market, saying that the benefits outweighed the risks. However, the panel also voted 21 to 5 in favor of adding stronger warnings to the side effects label, specifically about the risk of Yasmin blood clots.
Among the evidence the panel considered was an FDA study that found that every year, 10 out of 10,000 women taking pills with drospirenone would get a blood clot, versus six in 10,000 women for those taking contraceptives that do not contain dropirenone.
Controversy over perceived conflicts of interest
During the December meeting, some women’s advocacy groups complained that other studies the FDA looked at which did not show an increased risk of blood clots were funded by Bayer or the contraceptive industry, and were thus not reliable or objective.
It was later revealed that four of the FDA’s advisors on the panel had previous ties to manufacturers of drospirenone-containing contraceptives. In light of this perceived conflict of interest, in January the U.S. watchdog group the Project on Government Oversight called for the FDA to hold a new vote on the contraceptives.
On March 9, 2012, four women’s groups jointly sent a letter to FDA Commissioner Margaret Hamburg expressing concern that the FDA’s decision to keep drospirenone-containing birth control pills on the market would endanger women’s lives.
Yaz MDL trials postponed for mediation
Thousands of women have hired a Yaz lawyer and filed litigation against Bayer over blood clots. More than 6,600 of these lawsuits were consolidated into a multidistrict litigation (MDL) in Illinois. However, Chief Judge David R. Herndon, the judge overseeing the MDL, has pushed back the start of trials several times, encouraging the parties to seek resolution through mediation.
Yaz (a reformulated version of the older Yasmin) is a bestselling contraceptive that had $374 million in sales in 2010. However, in recent years, generic versions have been put on the market by Teva Pharmaceutical Industries and Watson Pharmaceuticals, which has cut into Yaz sales.