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France ignores EMA and suspends Bayer's Diane 35

National Agency for the Safety of Drugs and Health Products contradicts PRAC verdict

France suspends Diane 35 despite EMA recommendation

Regulators in France have decided to suspend sales of Bayer's acne treatment Diane 35 despite a recommendation from the European Medicines Agency (EMA) that the drug's benefits outweighed its risks.

Last week, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) decided Diane 35, and generic versions of the treatment, could still be used in a limited group of patients, but France's National Security Agency for Medicines and Health Products (ANSM) wants to wait until a final Europe-wide decision is confirmed.

The European review was prompted by the ANSM after the regulator grew concerned about the link between several blood clot-related deaths and Diane 35, which combines cyproterone acetate and ethinyl estradiol to suppress the activity of several hormones.

These issues caused the ANSM to announce sales of Diane 35 and its generics would be suspended from today, a decision the regulator has stuck to despite the PRAC's subsequent findings.

In a statement explaining its decision, the ANSM said that the thromboembolic risk of the drug was "not sufficiently taken into account in practice”.

The French regulator, which was formed last year after several high profile failures from its predecessor AFSSAPS, also highlighted that the drug is often used off-label as a hormonal contraceptive, meaning much of its use was outside the scope of authorisation.

The PRAC did account for this off-label use in its recommendation, stating that Diane 35 and its generics should not be taken in combination with other hormonal contraceptives, but the ANSM said it will not budge on its stance until the PRAC's proposals have been confirmed by the Coordination Group for Mutual procedures and decentralised recognition - Human Medicines and then approved by the European Commission.

“It is after this last step that all security measures for the use of these drugs can be implemented and applied in all Member States, including France,” said the ANSM.

Responding to the ANSM's “unexpected” announcement, the EMA stuck by the PRAC's view that the benefits of Diane 35 and its generics outweighed its risk in certain groups of patients with acne.

The Agency said: “The PRAC adopted this recommendation with a 31:1 majority, following a thorough review of these medicines in which it sought expert advice and considered feedback from users of these medicines.”

21st May 2013

From: Research, Regulatory



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