France has suspended sales of acne treatment co-cyprindiol today (May 21), despite the European Medicines Agency (EMA) concluding that the therapy's benefits outweigh the risks.

The French medicines agency (ANSM) announced it was pushing forward with its plans to suspend the marketing authorisation of products containing co-cyprindiol, including the brand Diane 35, last week (May 17) after raising initial concerns in February. 

The move comes despite the EMA announcing on the same day that the drug, branded Dianette in the UK, had "a place as a treatment option for certain women", following a Europe-wide review of the therapy. UK medicines watchdog the MHRA also advised this week that co-cyprindiol was an "effective medicine" for the treatment of severe acne and women should continue to take it.

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	The ANSM called for a European review of the drug in February in light of an investigation in France that linked it to the deaths of four women from venous thrombosis since it was introduced in 1987. There were 125 additional cases of thrombosis in women who had used the drug over the same period, the ANSM reported.

The EMA said last week that the benefits of Diane 35 and its generics outweighed the risks, provided that several measures were taken to minimise the risks of thromboembolism.

It did, however, issue new contraindications and warnings. It stressed that co-cyprindiol should only be used to treat severe acne or hirsuitism in women of reproductive age and only for the treatment of acne when alternative treatments, such as topical therapy and oral antibiotic treatment, have failed.

It also advised that the drug should not be taken in combination with other hormonal contraceptives.  

The ANSM said on Friday (May 17) that it had taken note of the EMA recommendation but was awaiting a final decision from the European Commission.

The MHRA advised this week that there was no need for a woman who was feeling well to stop taking the medicine. "If a woman has any concerns about her treatment she should contact her doctor," it said.