France’s drug watchdog said Wednesday it was suspending sales of acne drug Diane-35 and its generic versions, which many women also use as a contraceptive, after four women died and more than 100 others developed blood clots in the past 25 years.
The National Agency for the Safety of Drugs and Health Products said the suspension would be phased in over the next three months to allow the more than 300,000 women in France taking the hormonal treatment to find an alternative drug, Agence France-Presse reported.
Diane-35, which is produced by German drugmaker Bayer, reduces acne by regulating hormones and blocking ovulation, which is why it is also prescribed as a contraceptive even though it is not approved for this use.
It is sold in more than 116 countries.
New data cited by the French regulator shows “an elevated risk of thrombosis among women taking the treatment,” Dow Jones Newswires reported.
The watchdog earlier this week had announced an inquiry into the pill after the deaths of four women due to blood clots were linked to the drug, Reuters reported.
Another three deaths were possibly linked to the drug.
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