France's drug regulator identified 4,100 children born with birth defects after their mothers took Sanofi's epilepsy drug valproate between 1967 and 2016, reports Reuters.
Valproate, which also treats bipolar disorders, may hinder children's neurological development, the French National Agency for Medicines and Health Products Safety said April 20.
While Sanofi said it's been transparent with authorities regarding risks of the drug, parents of the affected children say France and the drugmaker were too slow to warn the public of the side effects — even after the risk to fetuses became apparent in the early 1980s, reports Reuters.
The Food and Drug Administration in 2013 issued a warning for valproate, saying the drug should not be taken during pregnancy. A Paris-based prosecutor in 2015 launched an initial investigation into the drug after a group of families filed a legal complaint, according to the report.
The French National Agency for Medicines and Health Products Safety plans to publish a study on the neurological effects of valproate in the second half of 2017.
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