French doctors are told to restrict use of third and fourth generation oral contraceptivesBMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f121 (Published 08 January 2013) Cite this as: BMJ 2013;346:f121
France is taking steps to stop the overprescription of third and fourth generation oral contraceptives after a legal case highlighted the fact that many women are running an increased risk of serious side effects by taking the pills when alternatives are available.
In the first case of its kind in France, Marion Larat, 25, sued the German drug company Bayer and the head of the French drug regulatory board, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), in December after she had a stroke while taking Bayer’s third generation pill Meliane (gestodene with ethinylestradiol). She believes that the drug should have been withdrawn from the French market.
Her case has provoked alarm in a country where half of the five million women taking oral contraceptives are using later generations of pills. These products are known to reduce side effects caused by previous versions, such as weight gain and acne. Studies have shown that the risk of venous thromboembolism is twice as high for women using third and fourth generation pills than for those using earlier versions, although it remains low.1 ANSM has advised that later generation pills should never be used as a first choice and only if patients have problems with earlier versions.
The regulatory body has insisted that the newer pills should remain on the market, as they are beneficial to some. But it has announced that from April they will no longer be reimbursed by the social security system. Doctors are being urged to refrain from prescribing the later versions. Health officials are also expected to announce further steps, which may include stripping midwives and nurses of their power to prescribe contraceptives or introducing systems to oblige patients to try older pills first.
“It’s a peculiarity of the French system that when a new drug comes along it gets prescribed a lot,” said a spokesperson for ANSM. “Today, third and fourth generation contraceptives are the pill of choice for young people. We are working to reverse that trend and get back to the correct usage.”
Bayer said in a statement that it was waiting for detailed information about the allegations against it but defended Meliane. “Based on a thorough assessment of the available scientific data by regulatory authorities, external independent experts, and Bayer scientists, combined oral contraceptives are safe and effective and have a favourable benefit risk profile when used as directed,” the company said.
In the United States Bayer has paid out $750m (£470m; €570m) in compensation after nearly 3500 legal claims that its third generation pill Yasmin caused deep vein thrombosis or pulmonary embolism, the company said.2 Another 3800 cases are pending there. Larat’s lawyer has indicated that some 30 other women are now preparing to launch similar legal proceedings against several different drug companies.
Cite this as: BMJ 2013;346:f121