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France Suspends Bayer Diane 35: Post-Mediator Strictness Or Prelude To Broad Withdrawal?

 
• By Faraz Kermani

France has announced the suspension of Bayer’s acne drug, which is widely used as a contraceptive, after confirming its role in the death of four patients; a subsequent referral to the EMA could herald a Europe-wide suspension.

France’s first big test for its new pharmacovigilance system could also be a significant test for oral contraceptives and how regulators in many regions are considering their risk-benefit tradeoffs.

On January 30, the French Medicines Agency, ANSM, said it would temporarily suspend the marketing authorization for Bayer AG’s Diane 35 (cyproterone 2 mg/ethinyl estradiol 35 mcg) and generic...

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