France investigates Diane-35 acne drug after deaths

PARIS Sun Jan 27, 2013 5:14am EST

PARIS Jan 27 (Reuters) - France's health regulator has opened an inquiry into acne drug Diane-35, which is also used as a contraceptive, after four deaths linked to the drug in the past 25 years.

Health regulator ANSM said on Sunday that Diane-35, produced by German drugmaker Bayer, is authorised in 135 countries and sold in more than 116. Last year about 325,000 women in France used the drug, ANSM said, adding it would publish its report next week.

ANSM said the four deaths were due to thrombosis linked to the use of Diane-35. Three other deaths possibly connected to the drug, reported by the media, were linked to other health issues, the agency said.

Diane-35, also sold as Dianette in some countries, reduces acne for women by regulating hormones, according to several medical websites. The drug is also used as a contraceptive.

Earlier this month, ANSM said it was studying the possibility of limiting the use of third- and fourth-generation contraceptive pills after a woman sued Bayer over alleged side-effects such as embolism, or blood clots. (Reporting by Geert De Clercq; editing by Jane Baird)

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