Sanofi drug caused up to 4,100 severe birth defects, says regulator

21 April 2017

The French National Agency for the Safety of Medicines (ANSM) has released a study showing up to 4,100 children were born with a severe congenital disorder after being exposed in the womb to valproate, a Sanofi product.

The drug, which has been available since 1967, is sold under the name Depakine for the treatment of epilepsy, and as Depakote and Depamide in bipolar conditions.

The defects cited in the report include spina bifida, in which the spinal cord forms in an irregular manner, and problems related to the heart.

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