France pulls out Diane-35 from the market

January 30, 2013 | By Márcio Barra

Following yesterday’s news, today the National Agency for the Safety of Drugs and Health Products (ANSM), the French national authority on drugs, announced it is going to suspend the sales of Diane-35, an acne drug also used off brand as a hormonal contraceptive.

The agency, in a press conference held today in Saint-Denis, stated that the market suspension will occur over a period of three months, allowing the roughly 315,000 women who use Diane-35 to find an alternative drug. French doctors will no longer be able to prescribe the medicine. This comes after a benefit-risk assessment on the basis of its use as an acne treatment turned out negative, said Mr Maraninchi, the agency’s director.

In Portugal, Diane-35 is sold as a short term hormonal contraceptive.

Additionally, Infarmed reports that no deaths have occurred in Portugal due to its use since it went on sale in 2009.


The Telegraph

Notícias ao minuto


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