Acne drug linked to deaths in France


France faces another damaging health scandal after its medical authorities confirmed four deaths in the past 25 years were linked to an acne drug prescribed by doctors as a contraceptive.

Amid growing concern about third- and fourth-generation birth control pills, a secret report by France’s drug safety authority revealed 125 women had suffered “undesirable” and possibly life-threatening side effects linked to Diane-35 or its generics.

Le Figaro newspaper, which obtained a copy of the confidential internal document produced by the agency, said 37 of the women had not fully recovered after taking the pills made by German pharmaceutical firm Bayer.

An estimated four to five million boxes of Diane-35 are sold in France every year.

Dozens of lawsuits against third- and fourth-generation contraceptive pills – known as the combined pill – have been launched in France by women who have suffered side effects.

The French government has advised doctors to limit the prescription of some contraceptive pills and will stop reimbursing patients the cost of those drugs from April. Critics describe the move as folly.

The Agence Nationale de Sécurité du Médicament said yesterday Diane-35 had been authorised for sale in France since 1987, but only for acne. It said it had looked into the side-effects of the drug and its generics and would publish its findings this week. It was also investigating doctors’ prescription habits.

Earlier this month the president of the French cancer institute, Prof Dominique Maraninchi, said several ongoing inquiries showed the “non-authorised use” of Diane-35 was “significant”.

French authorities made headlines recently over Mediator, a diabetes drug widely prescribed as an appetite suppressant, which is believed to have killed at least 500 people. – (Guardian service)