French Government Pulls Bayer Acne Drug Over Deaths

French Government Pulls Bayer Acne Drug Over Deaths

January 30th, 2013 // 4:07 pm @

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Two days after launching an investigation into four deaths linked to the Diane-35 acne medicine sold by Bayer, which is also prescribed as a contraceptive, French authorities have halted the sale of the drug. More than 300,000 women are using the drug for contraception, according to the National Agency for the Safety of Drugs and Health Products.

The deaths were attributed to venous thrombosis, a risk that has been noted with the drug and an issue that prompted French authorities to ask the European Medicines Agency to change prescribing guidelines for third- and fourth-generation oral contraceptives after the drugs were found to carry a higher risk of blood clots compared with earlier versions of the medicines (see this).

Since 2011, French authorities have been reviewing the risks and benefits of medicines that were approved for use prior to 2005. And they note that, since 1987, 113 other non-fatal cases of venous thrombosis have been reported (see a question-and-answer summary here). The suspension also covers generic versions.

“This drug is not licensed for use as a contraceptive,” ANSM director Dominique Maraninchi told a press conference, according to France24. “…But it is being used as such, in this secondary role… yet there are plenty of other alternative contraceptives that can be used in this country.”

The move to suspend sales is significant because this signals a tougher stance by authorities in a major Western market toward safety, an issue that in recent years has plagued other regulators – notably the FDA in the US – years after several controversies. French authorities have been haunted by one scandal, in particular, that appears to be shaping regulatory thinking.

This involved the Mediator pill that was sold by Servier as an appetite suppressant for overweight diabetics and linked to heart-valve damage. Government investigators contended the risks were deliberately concealed. As many as 5 million people took the pill between 1976 and November 2009, when it was withdrawn – several years after it was yanked in Spain and Italy.

French health inspectors say Mediator should have been withdrawn a decade earlier. The government was lambasted after a former health minister was linked to the controversy following reports that two of his former advisers – a doctor and a public health expert who was in charge of research at the ministry – had once worked for Servier.

Last month, 9o-year-old Jacques Servier, who founded Servier Laboratories, was formally placed under investigation on suspicion of manslaughter in connection with his role in the scandal over the Mediator diabetes drug, which has since been blamed for at least 500 deaths in France


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