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

 
• By Cathy Dombrowski

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.

An FDA advisory panel will consider Dec. 8 whether conflicting evidence on the risk of venus thrombotic and thromboembolic events for combination oral contraceptives containing progestin drospirenone warrant labeling changes for the drugs.

A number of epidemiological studies have reached opposite conclusions about the drugs’ safety with regard to VTE and arterial thrombotic events, so there is no definitive answer on this safety issue, FDA says in briefing documents for the joint meeting of

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