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EMA says Bayer's Diane 35 should remain on European market

Agency investigation concludes acne treatment's benefits outweigh its risks

Bayer's Diane 35 to remain on European market

Bayer's controversial acne treatment Diane 35 is to remain on the market in the EU after an investigation determined the benefits of the drug outweighed its risks.

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) said Diane 35 or generic versions of it should only be used in a restricted population, however, due to the risk of blood clots.

This revised recommendation covers treatment of acne when alternative treatments, such as topical therapy and oral antibiotic treatment, have failed, as well as the treatment of moderate to severe acne related to excessive unwanted growth of hair in women of reproductive age.

Diane 35 is also sometimes used off-label as a hormonal contraceptive and the EMA said that women should not take it in combination with other hormonal contraceptives as this would increase the risk of blood clots.

The future of Diane 35 has been under threat since the French drug regulator the National Security Agency for Medicines and Health Products (ANSM) became concerned with the drug's links to several deaths due to embolism and cerebral thrombosis.

This led to it being suspended in France, while the EMA launched an investigation into the safety of Diane 35, in addition to a wider review of third- and fourth-generation oral contraceptives.

The EMA explained the decision to keep Diane 35 and its generics on the market, saying: “The risk of venous thromboembolism occurring with these medicines is low and well known, and warnings are included in their product information to alert patients and prescribers to the risks.”

As part of the revised recommendation, the PRAC also suggested that efforts be made to raise awareness of the risks, signs and symptoms of thromboembolism. This includes educational materials for prescribers and patients, such as a prescriber checklist.

On top of this, the PRAC also recommended further pharmacovigilance activities, including a post-approval safety study to assess the effectiveness of the risk-minimisation measures.

The recommendations from the PRAC will now be considered by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) before being confirmed.

20th May 2013

From: Regulatory



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