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A French association of people affected by an epilepsy drug that caused birth defects launched a class action against pharmaceutical company Sanofi on Tuesday.

APESAC President Marine Martin told The Associated Press that Sanofi now has four months to acknowledge its responsibility before a judge takes up the case.

The global drug company has been selling Depakine, the anticonvulsant drug at the center of the class action, in France since 1967.

Depakine, which contains sodium valproate, is usually prescribed to treat epilepsy.

Sanofi said in an email to the AP that it had received notification of the proceedings. The company declined to comment further.

A study revealed by Le Canard Enchaine newspaper found that Depakine was prescribed to more than 10,000 pregnant women in France between 2007 and 2014. Another report published in February estimated that around 450 children in France who were exposed to the drug while in the womb were born with congenital defects.


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