Sales of an acne drug, often prescribed by doctors as a contraceptive, were suspended in France on Wednesday after it was linked to the deaths of four women.
The National Agency for the Safety of Drugs and Health Products (ANSM) said it was suspending sales of a hormonal treatment called Diane-35, currently taken by 315,000 women in France, Agence France-Presse (AFP) reports.
According to ANSM’s website, over 25 years four women have died and 125 became ill with blood clots directly attributable to Diane-35.
Dominique Maraninchi, ANSM’s director, told a press conference that the drug will be withdrawn over three months to allow users to find a substitute.
Diane-35 is produced by German firm Bayer AG to treat acne in young women, but doctors have been prescribing it as a contraceptive because it stops ovulation, said Maraninchi.
“This drug is not licensed for use as a contraceptive,” he added. “[…] But it is being used as such … yet there are plenty of other alternative contraceptives that can be used in this country.”
Maraninchi said the agency had carried out a benefit-versus-risk assessment for Diane-35. Due to its negative result, the decision was taken to pull it from the French market.
The product is sold in 116 countries around the world. The dramatic decision to suspend its sales is just the latest health scare in France in recent years.
Other scandals involved breast implants, contraceptive pills, and an anti-diabetes drug called Mediator that was also used as a dietary aid but was later linked to heart failure, said Live Mint and Wall Street Journal.
Now the ANSM has asked the European Medicines Agency (EMA) to change prescription guidelines for more recently produced — so-called second and third generation — oral contraceptives after they were found to carry a higher risk of blood clots compared to earlier versions, AFP notes.
Have you ever taken Diane-35? If so, what were your experiences with the drug?