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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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Bayer updates labeling for its drospirenone-containing contraceptives to reflect potentially higher risks compared to other birth control pills as FDA seeks ways to get more definitive information.

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Uncertainty remained the dominant opinion about the risk for blood clots with the four Bayer contraceptives at the conclusion of a Dec. 8 joint meeting of the Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committees. One thing panelists were sure of was that they didn’t want a summary conclusion about the risks in labeling. But they didn’t want a lengthy discussion of data, either.

Bayer Contraceptives Win Advisory Committee Backing As Panel Rejects Call For Comparative Effectiveness

In a 15-11 vote, FDA advisory panel members split on whether drugs containing progestin drospirenone should be judged on absolute risk, or whether their potentially higher risk than other birth control pills should be offset by benefits beyond those provided by alternatives.

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