FDA Advisory Committee to Make Ruling on Yaz Safety Concerns

An upcoming FDA hearing on the health risks associated with Yaz birth control could aid in lawsuits filed by women who have suffered from Yaz and Yasmin side effects. Currently, Yaz contraception is still on the market, despite the FDA warnings. Any hearing that leads to a ban on the drug or increases the severity of the warnings would greatly impact the effectiveness of one’s case. Interestingly, in October 2008, Bayer Healthcare announced that it was facing 129 lawsuits regarding the side effects of Yaz and Yasmin. Since then, as more and more women have become aware of and been diagnosed with Yaz side effects, the number of Yaz lawsuits filed have risen significantly.

Yaz was FDA approved in 2006. In addition to being an FDA-approved contraceptive, Yaz is also approved for treating moderate acne in females older than 14 and premenstrual dysphoric disorder (PMDD), a severe form of PMS marked by depression, anxiety and sleeping problems. After Bayer acquired Berlex in 2006, they began marketing Yaz, a nearly identical drug. Both contain 3mg of drospirenone, with Yaz containing 0.02 mg of ethinyl estradiol per tablet, as opposed to Yasmin, which contains 0.03 mg of ethinyl estradiol per tablet.  A generic version, Ocella, is also now available. As a result of aggressive marketing without adequate warnings, the Yasmin family of pills are among the most popular methods of birth control.

The Bayer birth control pills Yaz and Yasmin may increase the risk of blood clots by as much as 75% when compared to older birth control pills, according to a study conducted by the FDA. The FDA is planning to hold a conference on December 8^th to review the “conflicting” studies that have indicated sharp increases of the risk of forming a Yaz blood clot, as compared to other oral contraceptives. Last week, the FDA released a new drug safety report on Yaz, Yasmin and all drugs made with the progestin drospirenone last week, announcing that its own study has found significant increased risk of blood clots with the contraceptive pills.