EU agency backs Pill after France blood clot scare

 

The European Medicines Agency (EMA) has had to reassure women about the safety of the contraceptive pill in response to public alarm that has swept France, where dozens of women are suing manufacturers for potentially fatal blood clots they suffered while taking it.

The French Health Minister, Marisol Touraine, demanded that the EMA “modify its market authorisation” for newer third and fourth generation pills, which carry a higher risk of blood clots, to ensure they were not prescribed as a first option.

But the EMA, which licenses drugs for use in the UK and across Europe, said in a statement there was “no new evidence” of any safety problem with “any combined contraceptives marketed today”. “Therefore there is no reason for any woman to stop using her contraception,” it added.

The controversy in France was triggered last month when 25-year-old Marion Larat filed a lawsuit after suffering a stroke while taking the contraceptive pill as a teenager. The student was left with a non-functioning right hand and impaired speech and mobility.

The third and fourth generation pills combine the female hormone oestrogen and a synthetic version of progestogen in an attempt to avoid the side effects associated with older versions, such as weight gain, mood changes and skin problems.

Third generation pills are known to carry a slightly higher risk of blood clots (25 per 100,000 women per year) than second generation (15 per 100,000). For fourth generation pills the risk is higher still. But pregnancy carries a risk of 60 per 100,000. Almost 2.4 million women in the UK take third and fourth generation pills according to the NHS Information Centre.

Comments