Paris - France's health regulator ANSM said on Wednesday that it would suspend sales of Bayer's acne pill Diane 35 and its generic versions after four deaths over the past 25 years were linked to its use.
About 315 000 women used Diane 35 or its generic version in France last year. Bayer said it was “surprised” by the suspension of the drug, which is sold in over 100 countries, typically under brand names including Dianette.
A box and blister-packs of the acne drug Diane-35, which is also used as a contraceptive, are seen in a pharmacy in Andernos, France. The country's health regulator on Wednesday said it would suspend Diane 35 and its generic versions within three months because it carries a high risk of blood clots. Credit: Reuters
Europe's drug regulator the European Medicines Agency (EMA) issued a statement late on Wednesday saying France had indicated its intention to ask for a European-led safety review of the medicine, but had not yet done so.
“Although (EU) member states can take unilateral action to suspend the marketing authorisation of a medicine, European legislation requires that there is a coordinated European approach in these instances,” the agency said in a statement.
It said once France made a formal request, its risk assessment committee would “evaluate all evidence on the benefits and risks of these medicines and give a recommendation on whether their marketing authorisations should be varied, suspended or revoked”.
Bayer said in a statement it was “not aware of any new scientific evidence leading to a change in the positive benefit-risk assessment of Diane 35”. The German drugmaker said it would work closely with ANSM to address questions on the drug.
The French agency said the four deaths linked to Diane 35 were due to blood clots, and three other deaths possibly connected to the drug were also linked to other health issues.
Diane 35 reduces acne by regulating hormones and blocking ovulation, and is often prescribed as a contraceptive even though it is not approved for this use.
ANSM said it would phase in the suspension over three months to allow women to switch to other treatments and French doctors will not be able to prescribe Diane 35 or its generic versions to new patients from Wednesday.
But in its statement, EMA said women in Europe 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 European regulator said.
ANSM said this month it was studying the possibility of limiting the use of third- and fourth-generation contraceptive pills, also made by Bayer, after a woman sued the German drugmaker over alleged side-effects including blood clots. - Reuters