France backs down on Diane 35 suspension after latest European review

French health regulators say they'll usher Bayer's hormonal pill Diane 35 back onto the market, if top European watchdogs ratify the latest recommendations from a drug-safety body. France had suspended the acne treatment and its generic versions in January, after four deaths were linked to its use.

The European Medicines Agency (EMA) stepped in at France's request after the death statistics were reported, to conduct a safety review of the Bayer product. Diane 35, approved as an acne fighter, had also been used off label as a contraceptive.

Earlier this month, the EMA concluded that the drug's benefits outweigh its risks. The agency backed Diane 35 for use as an acne treatment only, noting that it shouldn't be used in combination with hormonal contraceptives, because of the risk of blood clots. Now, European Union higher-ups have endorsed the EMA's recommendations, and the European Commission is expected to issue a legally binding decision in the coming weeks, Reuters reports.

So, if the EC continues the positive trend, Diane 35 will be allowed back onto the market in France. The country's restrictions on reimbursements for third- and fourth-generation contraceptives, also made by Bayer, remain in force, at least for now. Those pills, including the popular birth-control drugs Yaz and Yasmin, have been under scrutiny for some time on worries that they raise the risk of blood clots more than older contraceptive pills do.

- read the EMA release
- see the AFP news
- get more from Reuters

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