A recent Food and Drug Administration (FDA) review, which studied 800,000 people, delves into the side effects of Yaz and Yasmin birth control pills. If the FDA finds that the products' side effects are worse than those of other oral contraceptives, pending and future Yaz lawsuits will be affected.
Newer oral contraceptives (birth control pills) use a progestin called drospirenone, which replaces levonorgestrel, the progestin most commonly found in older brands. While all birth control pills raise a patient's risk of developing yaz blood clots, the issue is whether women taking Yaz or Yasmin may run an even higher risk.
Two recent studies showed that women who took birth control pills containing drospirenone did have a higher risk of blood clots. Two additional studies published in 2009 came to a similar conclusion, stating that women who used products containing drospirenone had a higher risk of blood clots than women who took products with levonorgestrel. However, two additional post-marketing studies – required by both the FDA and European regulatory agencies – reviewed the risks and side effects of drospirenone and did not find an increased possibility of blood clots among those patients who took drugs containing drospirenone.
In May 2011 the FDA announced that it would continue review of drospirenone products, and would analyze all data from their large, self-funded study on oral contraceptives and blood clots. Although the administration's drug-safety communication originally estimated that results would be available in late summer 2011, the FDA has not released any additional information or conclusions as of September 2011.
Meanwhile, lawyers for Yaz and Yasmin have been preparing for battle. Almost 7,000 lawsuits have been filed as of September 2011, these for side effects ranging from gallbladder disease to blood clots. Pennsylvania will see the first Yaz lawsuit to go to court in federal multidistrict litigation, as well as centralized litigation. The Pennsylvania case was filed due to a yaz pulmonary embolism, a blood clot in the lungs that is a potentially deadly and very serious disease – and one of the most common side effects of oral contraceptives that contain drospirenone.
If the FDA study finds that blood clots are more common in products containing drospirenone, these 7,000 lawsuits will have additional evidence in their favor. In that case, Bayer, the company that owns the Yaz and Yazmin products, may consider settling out-of-court.
