French health authorities said they plan to suspend sales of Bayer AG’s Diane 35 acne treatment, which is often used as a birth-control pill, amid concern the medicine increases the risk of blood clots.
A review of the treatment’s risk-benefit balance proved to be “unfavorable,” Dominique Maraninchi, director general of the Agence Nationale de Securite du Medicament et des produits de Sante, said today. The suspension will take “full effect” in three months, he said. France wants a Europe-wide review of Diane 35 and its generics, the European Medicines Agency said.
Diane 35 “isn’t approved for use as a contraceptive,” Maraninchi told reporters during a press conference in Saint-Denis, outside of Paris.
Starting today, French doctors will no longer have the right to prescribe the medicine, Maraninchi said. Pharmacists will be allowed to sell the treatment in limited quantities to women using it until they have the time to get a different prescription, he said. About 315,000 women in France use Diane 35 or a generic version of the drug, according to the regulator.
“We are surprised by this action taken by the ANSM,” Astrid Kranz, a Bayer spokeswoman, said in a statement. “We are not aware of any new scientific evidence leading to a change in the positive benefit-risk assessment of Diane 35.”
French authorities are probing Diane 35 after the medicine was linked to four deaths from blood clots in the past 25 years, the regulator, best known as ANSM, said this month.
ANSM has been moving quickly to avoid criticism such as that caused by a scandal involving Les Laboratoires Servier’s Mediator, a medicine pulled from the market after 33 years in 2009 over concerns it caused heart-valve damage and deaths.
Once a request from France for a review has been received, the European Medicines Agency’s pharmacovigilance risk assessment committee will evaluate all evidence on the benefits and risks of Diane 35 and its generic equivalents, and give a recommendation on whether their marketing authorizations should be “varied, suspended or revoked, in the interest of all patients in the EU,” the EMA said in a statement today.
Pending the outcome of the panel’s review, women who are currently taking Diane 35 or one of its generics are advised not to stop the medicine. If a woman has concerns, she can discuss this with her doctor, the London-based agency said.