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As many as 4,100 children were born with major birth defects due to a Sanofi epilepsy drug that was taken by women who were being treated for epilepsy or bipolar disorder, according to a report by the ANSM, the French National Agency for Medicines and Health Products Safety.

Between 1967 and 2016, anywhere from 2,150 to 4,100 children were born with at least one major congenital disorder after being exposed to valproate, which is known as Depakote for treating bipolar disorder and Depakine for treating epilepsy. During that time, between 64,100 and 100,000 pregnancies in France were exposed to the medicine.


In its preliminary report, the regulator found that the risk of major congenital malformations compared to the general population was four times higher in children born to a woman who took the medicine for epilepsy, and twice as high for those women who were treated for bipolar disorder. Why the discrepancy? Patient adherence is likely worse among those suffering from epilepsy, ANSM suggested.

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