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Non-Contraceptive Use Could Confound Safety Evaluation Of Drospirenone-Containing Products

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA will seek advisory committee input Dec. 8 on whether and how to adjust labeling and to conduct further studies for contraceptives containing progestin drospirenone because of the drugs’ potential risk for venus thrombotic and thromboembolic events. The agency has a specific study design in mind that it wants sponsors to conduct.

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