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MHRA has 'no new concerns' over co-cyprindiol despite French ban

Clinical The MHRA has confirmed it has “no new concerns” about acne drug Dianette, despite France’s decision to suspend all sales of the drug after the deaths of four women from venous thrombosis.

The MHRA has confirmed it has "no new concerns" about acne treatment co-cyprindiol, despite France's decision to suspend all sales of the therapy.

The French medicines agency ANSM announced plans to suspend the marketing authorisation of products containing co-cyprindiol, including the brand Diane 35, yesterday (January 30), following an investigation that linked the drug to the deaths of four women from venous thrombosis since it was introduced in 1987.

There were also 125 cases of thrombosis in women who had used the drug over the same period, the ANSM reported.

"Despite recent developments in France, we have no new concerns and there is no need for a woman who is feeling well to stop taking her medicine" MHRA spokesperson

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The MHRA told C+D that co-cyprindiol, available in the UK as Dianette, was an effective medicine and advised women who had any concerns about their treatment to contact their doctor.

"Despite recent developments in France, we have no new concerns and there is no need for a woman who is feeling well to stop taking her medicine," an MHRA spokesperson said.

However the European Medicines Agency (EMA) announced it would be carrying out a Europe-wide review of the treatment, once it had received a formal request from the ANSM. This could result in a recommendation for the manufacturing of the drug to be varied, suspended or revoked, the EMA said.

The EMA advised women to continue taking the drug until its review is completed.

Co-cyprindiol, or cyproterone acetate and ethinylestradiol, is licensed for the treatment of severe acne and hirsutism (abnormal hair growth). In 2011 it was dispensed more than 280,000 times in the UK.

Although the drug also acts as an oral contraceptive, the MHRA recommends that it is not used solely for this purpose.  

The MHRA said the Commission on Human Medicines had previously reviewed the safety of co-cyprindiol and concluded that the benefits outweighed the risks, the regulator said.

Although EU member states can individually suspend sales of a drug, European legislation requires a coordinated response across Europe, the EMA said.


Do you agree with the MHRA's stance in light of the French ban?

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