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No new risk with combined contraceptives: EMA

World News | January 14, 2013


Kevin Grogan

No new risk with combined contraceptives: EMA

The European Medicines Agency has issued a statement saying that "there is no reason for any woman" to stop using combined contraception amid safety fears.

The agency said it is commenting after "growing media reports about combined contraceptives and venous thromboembolism - blood clots in veins". At the beginning of January, the French government said it would stop reimbursement of so-called third and fourth-generation pills and restrict their use after a woman sued Bayer after suffering  a stroke, caused by a blood clot, after using Meliane (gestodene/ethinylestradiol).

At a press conference last Friday, reported by Reuters, France's health minister Marisol Touraine said the newer pills, which reduce side effects from earlier versions such as weight gain and acne, should only be prescribed by specialists to women who cannot use other types of contraception. Dominique Maraninchi, head of the country's health regulator AFSSAPS, (the Agence Française de Securite Sanitaire des Produits de Sante), said at the same conference that "we will ask Europe not to suspend the pills but to modify prescription guidelines".

In response, the EMA says "it is well-established that combined contraceptives carry a very rare risk of blood clots, and that the risk differs" between different types of products. However, they are "constantly and rigorously kept under close monitoring [and] there is currently no new evidence that would suggest any change to the known safety profile of any combined contraceptives marketed today".

The agency added that at the current time it has "not received new evidence from any member state in relation to venous thromboembolism associated with combined contraceptives".

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