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FDA Remains Inconclusive Regarding Drospirenone Study Results

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FDA drospirenone studyThe FDA has communicated a luke warm statement about the safety of birth control pills containing drospirenone, stating that it “has not yet reached a conclusion and remains concerned.”

Consumers continue to await the final results of the FDA-funded study of the risks of drospirenone-containing birth control pills such as Yasmin, Yaz, and Beyaz. But the FDA says that preliminary results suggest an approximately 1.5 fold increase in the risk of blood clots for women who use those pills when compared to users of “other hormonal contraceptives”.

A joint meeting to discuss the risks and benefits with other safety committees is scheduled on December 8, 2011. At that time the final results of the FDA study should be released. Consumers anxiously await a full report of the study to determine whether it is consistent with findings earlier this year of a 2-4 fold risk of blood clots compared to users of second generation oral contraceptives.


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