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France will ask EU to curb use of newer birth control pills
January 11, 2013 / 3:10 PM / 5 years ago

France will ask EU to curb use of newer birth control pills

PARIS, Jan 11 (Reuters) - French health authorities will ask the European Union to restrict the use of newer types of contraceptive pills over concerns they might carry health risks.

France’s health minister Marisol Touraine said on Friday the newer pills, which have caught on because they reduce side effects from earlier versions such as weight gain and acne, should only be prescribed by specialist doctors to women who cannot use other types of contraception.

Dominique Maraninchi, head of France’s health regulator, said at the same news conference: “We will ask Europe not to suspend the pills but to modify prescription guidelines.”

While all oral contraceptives are associated with a risk of blood clots, a number of studies suggest the most recent third and fourth-generation pills carry a higher risk than their predecessors.

The European Medicines Agency (EMA) says the risk of an embolism, or blood clot, is twice as high for women using third and fourth-generation pills than for those using earlier versions, although it remains low.

However, the regulator said on Friday it was already well known that the newer pills carried a “very rare risk of blood clots”, and that there was no reason for women to stop using the contraceptives since there was no new evidence pointing to safety risks.

The French government said last week it would stop reimbursing prescription costs of the third and fourth-generation pills and would restrict their use after a woman sued German drugmaker Bayer over alleged side effects.

Marion Larat, 25, sued over a stroke, caused by a blood clot, she suffered following use of a third-generation contraceptive pill.

About 2.5 million women in France take third and fourth-generation pills, roughly half the number of those taking oral contraceptives. French health authorities say this use of the newer pills is excessive.

A spokeswoman for the EMA said the agency had been in informal contact with French health authorities but had not yet received an official request to consider a European-wide curb.

“We will see what the request will be in detail,” she said.

In addition to Bayer, drugmakers Pfizer, Merck , Mylan and Teva market third and fourth-generation birth control pills in France.

In October, Bayer said it had set aside 200 million euros ($264 million) in the third quarter for litigation in the United States in connection with its Yasmin/Yaz birth control pills, having already agreed to pay $750 million to settle 3,490 legal claims that Yasmin caused blood clots.

Clots are alleged in a further 3,800 pending cases.

Switzerland’s biggest health insurer CSS said earlier this week it was supporting a young woman in her claim against Bayer after she suffered a clot that left her severely disabled.

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