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Bayer’s Diane 35 faces ban in France

Follows investigation into blood clot-related deaths

Regulators in France have suspended the sale of Bayer's acne drug Diane 35 and its generics citing an increased risk of blood clots.

The decision by the National Security Agency for Medicines and Health Products (ANSM) follows an investigation into several deaths associated with the drug, which has been available in France since 1987 and is also used off-label as a form of birth control.

As previously reported, the deaths of four women have been directly attributed to use of Diane 35 or a generic, with three women dying due to embolisms and one due to cerebral thrombosis.

There have also been 125 additional cases of thrombosis reported since 1987 in patients taking Diane 35 or one of its generics, with dozens still yet to recover fully.

The ANSM said it plans to implement the ban on Diane 35 and its generics within three months, claiming that on top of the increased safety risk, the drug's effectiveness in treating acne was only moderate and alternative treatments are available.

The ban is likely to affect a larger number of women in France, with the ANSM stating that during 2012, 1.45 million boxes of Diane 35 and its generics were sold in France, with around 315,000 consuming the medicine each day.

A large number of women affected by the band will be using the drug as a contraceptive, with the ANSM reporting that 54 per cent of general practitioner prescriptions for the drug are for birth control, compared to just 40 per cent for acne.

At the moment, the ban only applies to France, although the European Medicines Agency (EMA) stated that member states can take unilateral action to suspend the marketing authorisation of a medicine.

There is a chance that a ban may be implemented Europe-wide, however, as the ANSM has stated it will request the European Medicines Agency (EMA) carry out a European-wide review of Diane 35 and its generics.

Once this request is received by the EMA, the agency's Pharmacovigilance Risk Assessment Committee will carry out an investigation into the medicine and give a recommendation covering the EU.

In the meantime, the EMA advises that women currently taking Diane 35 or a generic should not stop the medicine, but should discuss any concerns with a doctor.

31st January 2013

From: Sales, Regulatory

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