(Adds statement from European Medicines Agency, Bayer reaction)
PARIS, Jan 30 (Reuters) – France’s health regulator ANSM
said on Wednesday 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.
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.
(Reporting by Elena Berton and Pauline Mevel in Paris,
additiognal reporting by Kate Kelland in London.; Editing by
Louise Ireland and Jason Webb)
