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European agency defends existing advice on later generation contraceptive pills

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f279 (Published 14 January 2013) Cite this as: BMJ 2013;346:f279
  1. Sophie Arie
  1. 1London

France has called for a Europe-wide change in how later generation oral contraceptives are prescribed, because of the risk of side effects, but the European Medicines Agency has said that so far there is no new evidence to justify additional regulations.

At a press conference on Friday France’s health minister, Marisol Touraine, said that she would ask the agency to “modify” its market authorisation for third and fourth generation contraceptive pills. She also called for clearer warnings to be provided about the risks of venous embolism associated with the newer pills.

“The objective is that these pills are no longer prescribed to women as a first option,” she said.

The call came amid a scare in France over the case of Marion Larat, a 25 year old woman who sued the French drug regulatory board ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) and Bayer, the maker of the third generation pill Meliane (gestodene with ethinylestradiol), which she believes caused a stroke that left her partially paralysed.1

The case is the first of its kind in France, but Bayer has faced many similar legal cases in the United States over another third generation pill, Yasmin (drospirenone and ethinylestradiol). Larat’s lawyers said that at least a dozen other women were preparing similar lawsuits in France. In Switzerland a woman has also sued Bayer over a pulmonary embolism that she believes was caused by taking Yasmin.

But the European Medicines Agency insisted in a press statement that it was already well known that the pills “carry a very rare risk of blood clots.” It said that the risk differed among types of combined contraceptive.

The agency said, “These products are constantly and rigorously kept under close monitoring. There is currently no new evidence that would suggest any change to the known safety profile of any combined contraceptives marketed today. There is no reason for any woman to stop using her contraception.”

Third and fourth generation pills contain synthetic versions of progestogens and do not provoke some minor side effects associated with older versions of the pill, such as weight gain and acne. The agency said that the risk of venous thromboembolism was twice as high in women using these pills than in those using the earlier ones, although the risk remained low. The risk of a stroke was the same.

Under European rules countries must accept drugs that are approved by the agency, but this does not prevent national authorities making recommendations on how the drugs are used.

Countries are also allowed to suspend drugs from their market temporarily but cannot ban them.

France’s health ministry has already announced that it would stop reimbursing the prescription costs of third generation pills from 31 March. Until now half of the five million women using oral contraception in France have been taking third and fourth generation pills, which the ministry believes should be taken only by women who have a problem taking the earlier versions.

Notes

Cite this as: BMJ 2013;346:f279

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