France could be forced to overturn its suspension of acne treatment co-cyprinidiol after the EU medicines watchdog ruled that the therapy's benefits outweigh the risks.

The medicines regulatory body CMDh, which represents all EU member states, announced on Thursday (May 30) that it agreed with the European Medicines Agency's (EMA) decision that products containing co-cyprindiol, including the brand Diane 35, should be used as a treatment for moderate to severe acne.  

The announcement comes two weeks after the French medicines agency (ANSM) said it was pushing ahead with its plans to suspend the marketing authorisation of Diane 35, known as Dianette in the UK, after raising initial concerns about links to venous thrombosis in February. 

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	The EMA and CMDh recommendations will now be considered by the European Commission. Once it has made its final decision, all EU member states will have to follow it, ensuring that all measures to minimise any risks, including changes to the information to prescribers and patients, are implemented.

The ANSM called for a European review of the drug in February in light of an investigation in France that linked co-cyprindiol 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 concluded last month 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 MHRA has advised women in the UK to continue taking the drug unless they are feeling unwell and to contact their doctor if they have any questions about the therapy.