Over 14,000 women took
Sanofi epilepsy drug despite fetus risk: ministry
Send a link to a friend
[August 25, 2016]
PARIS (Reuters) - More than 14,000
pregnant women in France took Sanofi's anti-epilepsy drug Depakine
between 2007 and 2014 even though the risk of fetus malformation was
known, according to a study released by France on Wednesday.
Health Minister Marisol Touraine said in a statement that a second
part of the study, yet to be released, would focus on the impact on
children whose mothers took the drug.
Its active ingredient is sodium valproate and it has been sold under
different brand names. It can increase the risk of autism, arrested
development and deformation of facial features.
Touraine said parliament would vote on a compensation mechanism for
victims by the end of this year.
Parents of victims say Sanofi and the French state have been too
slow in warning about the side effects of the drug. Victims
association APESAC estimates that Depakine could have affected more
than 50,000 people since it was first sold in 1967.
"It is a sanitary scandal at the Sanofi laboratories with state
complicity," APESAC President Marine Martin told Reuters.
Sanofi said in a statement it would study the results of the report
but it had had no access to the information so far.
It said between 2007 and 2014 the information for doctors and
patients indicated that the drug was not suitable for pregnant women
because of the risk of malformation of the fetus and slower
Touraine said a pictogram would be added to the drug's packaging
within the next six months to warn clearly about the danger to
In a report published in February, French social affairs inspection
agency IGAS criticized the slow response of French health
authorities and Sanofi with regard to the risks related to Depakine
and its derivatives.
[to top of second column]
IGAS estimates that between 2006 and 2014 some 425 to 450 babies
suffered congenital birth defects or were still born following
exposure to the drug.
It said the drug has been on the market since 1967 and the risk of
fetus malformation was established in the early 1980s. Despite those
risks, the drug continued to be prescribed because of its
effectiveness against epileptic seizures and bipolar disorder.
In October, the Paris prosecutor launched a preliminary
investigation into the authorization and marketing of the drug.
(Reporting by Marine Pennetier and Geert De Clercq; editing by David
[© 2016 Thomson Reuters. All rights
Copyright 2016 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.