Sales of an acne drug called Diane-35 in France has been suspended following the deaths of four women who used it as a birth control pill. 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 on Wednesday it was suspending sales of a hormonal treatment called Diane-35, which is currently prescribed to 315,000 women in France.
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, made by the German firm Bayer, is authorised for treating acne in young women, but doctors have been prescribing it as a contraceptive because it stops ovulation, he says.
“This drug is not licensed for use as a contraceptive,” Maraninchi said.
“But it is being used as such, in this secondary role.
“Yet there are plenty of other alternative contraceptives that can be used in this country.”
Maraninchi said the agency had also carried out a benefit-versus-risk assessment for Diane-35 on the basis of its use as an acne treatment.
The assessment was negative, which explains why the drug was being suspended from the French market, he said.
Diane-35 is sold in 116 countries around the world, according to the ANSM website.
Over 25 years, four women have died and 125 fallen ill from blood clots attributed to Diane-35, according to ANSM.