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France investigates Bayer’s acne drug Diane 35 after deaths

Linked to blood clots in women

National Security Agency for Medicines and Health

Regulators in France are to investigate Bayer's Diane 35 and its generics after the acne treatment, which is also sometimes used off-label in birth control, was linked to several deaths.

According to a report by French newspaper Le Figaro, it obtained confidential information from the National Security Agency for Medicines and Health Products (ANSM) that in the country's pharmacovigilance database, seven women had died in circumstances linked to Diane 35 since it launched in 1987.

However, only four of these deaths are believed to be attributed directly to the drug, which has been associated with blood clotting, with three women dying due to embolisms and one due to cerebral thrombosis.

These events were confirmed by the ANSM in a public statement released after the article in Le Figaro, with the agency stating that in the other three cases, the cause of death was related to underlying disease of the patients concerned.

“These conditions appear to have played a key role in the death and taking Diane 35 does not seem offending,” said the ANSM.

The agency also confirmed that there have been further incidents of blood clotting in patients taking Diane 35 and its generics, with 125 other cases of thrombosis reported since 1987.

Of these, 113 were related to venous thrombosis and 12 to arterial thrombosis.

According to Le Figaro, of the 113 cases of venous thrombosis, 68 women recovered without complications, 7 recovered with complications and 30 are still not fully recovered.

The ANSM is now conducting an analysis of the risk-to-benefit profile of the drug, and will present data about its safety profile next week.

Following this, the agency said it will publish all the data related to Diane 35's safety and “take appropriate action”.

It is one of the first major patient safety investigations by the ANSM since it launched in May, 2012, following the dissolution of its predecessor AFSSAPS.

The AFSSAPS was closed after it became embroiled in the scandal concerning the withdrawal of Servier's diabetes drug Mediator (benfluorex), which has been linked with up to 2,000 deaths.

28th January 2013

From: Regulatory



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