France says will back down over Bayer acne pill

PARIS Thu May 30, 2013 10:52am EDT

An illustration picture shows blister-packs and a box of acne drug Diane-35, which is also used as a contraceptive, in a pharmacy in Andernos, Southwestern France, January 30, 2013. REUTERS/Regis Duvignau

An illustration picture shows blister-packs and a box of acne drug Diane-35, which is also used as a contraceptive, in a pharmacy in Andernos, Southwestern France, January 30, 2013.

Credit: Reuters/Regis Duvignau

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PARIS (Reuters) - France's health regulator said on Thursday it would comply with the European Commission if it ruled that Bayer acne pill Diane 35 and its generic versions were safe to use in some cases.

However, it added it would keep sales of the treatment on hold until then.

France is the only EU country where sales of the treatment were suspended earlier this year after four deaths over the past 25 years were linked to its use.

Diane 35 reduces acne by regulating hormones and blocking ovulation, and is often prescribed as a contraceptive even though it is not approved for this use.

Following a formal safety review, conducted at the request of French authorities, the European Medicines Agency concluded earlier this month that the benefits of Diane 35 outweighed the risks - provided measures were taken to minimize the chance of blood clots forming in veins and arteries.

These recommendations were endorsed on Thursday by a European Union body representing EU member states and will be sent to the European Commission, which will adopt a legally binding decision in the coming weeks.

The French government in January also stopped reimbursing prescription costs of third and fourth-generation birth-control pills and restricted their use after a woman sued Bayer over alleged side effects.

(Reporting by Elena Berton; Editing by Lionel Laurent)

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