Sunday Times 2
France suspends acne drug Diane 35 after four deaths
View(s):PARIS (AFP) – France has suspended sales of an acne drug that has been used as a birth control pill and linked to the deaths of four women. It is the latest health scare to erupt in France, coming after controversies involving later-generation contraceptive pills, breast implants and a pill used as a dietary aid that was linked to heart failure.
The National Agency for the Safety of Drugs and Health Products (ANSM) said it was suspending sales of a hormonal treatment called Diane 35 made by German firm Bayer.
The move will be phased in over three months to allow users to find an alternative drug, Dominique Maraninchi, the agency’s director, told a press conference.
The product is authorised for treating acne in young women, but doctors have been prescribing it as a contraceptive because it stops ovulation, he said.
Over 25 years, four women have died from blood clots attributed to Diane 35, according to ANSM, which said more than 300 000 women in France are using it as a contraceptive.
Bayer, in a statement to Agence France-Presse on Sunday, said the risk of clots “is a known effect, and is clearly marked as such in the package advice for patients.”
It added that Diane 35 should only be prescribed for acne, and “in the context of a medical consultation, with respect for appropriate use, side effects and precaution.”
Diane 35 is sold in 116 countries around the world, according to the ANSM website.
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