FDA: Study suggests increased risk of blood clots from drospirenone-containing contraceptives

On Monday, the United States Food and Drug Administration ("FDA") said its primary results of an agency funded study suggest a 1.5 fold increase risk of blood clots for women who use drospirenone-containing birth control products, such as Yaz and Yasmin.

The safety of Yaz and Yasmin is the subject of approximately 2,000 lawsuits filed in Pennsylvania before Philadelphia Court of Common Pleas Judge Sandra Mazer Moss, Coordinating Judge of the Complex Litigation Center.  Another 7,110 lawsuits are pending in federal court before the Honorable Judge David R. Herndon, who oversees the federal multidistrict litigation (MDL).  

The lawsuits allege that Yaz and Yasmin have risks beyond those of traditional birth control pills and that Bayer over-promoted the drug without disclosing the higher risks. Bayer was warned by the Food and Drug Administration (FDA), in the fall of 2008, that its television advertisements were misleading and did not disclose the additional risks.  

The FDA announced through its website that, "initial data from an FDA-funded epidemiologic study exploring the association of blood clots with several different hormonal contraceptive products, including levonorgestrel-containing contraceptives, appear consistent with results from the 2009 and 2011 published studies. Although FDA's review is ongoing, the preliminary data from the FDA-funded study are consistent with an approximately 1.5-fold increase in the risk of blood clots for users of drospirenone-containing contraceptives compared to users of other hormonal contraceptives."

Judge Moss appointed three Pennsylvania lawyers as Liaison Counsel for the plaintiffs, including Michael M. Weinkowitz of Levin, Fishbein, Sedran & Berman, Philadelphia; Daniel N. Gallucci of RodaNast, P.C., Lancaster, and Rosemary Pinto of Feldman & Pinto, Philadelphia.  Dianne M. Nast, RodaNast, P.C. was appointed Pennsylvania Federal-State Liaison Counsel by the Honorable David R. Herndon.