French authority indicted over sodium valproate-related birth defects
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French authority indicted over sodium valproate-related birth defects The National Agency for Medicine and Health Product Safety (ANSM) in France has been indicted for "injuries and involuntary homicides through negligence" due to its failure to stop women receiving sodium valproate [Depakine; Sanofi; and generic formulations] during pregnancy, resulting in congenital abnormalities and other disorders in their children, reports Owen Dyer from Montreal, Canada, in the BMJ. Since sodium valproate was first sold in France in 1967 for the treatment of epilepsy, approximately 17 000–30 000 children exposed to the drug in utero are estimated to have developed congenital abnormalities, developmental disabilities, autistic disorders or behavioural disorders, he said. The French government was declared liable for sodium valproate-related damages by an administrative tribunal in July 2020, and Sanofi was indicted for manslaughter in August 2020. A study conducted by ANSM physicians and others, based on data from the French National Health Data System in 1.7 million children, reported in October 2020 that in utero exposure to sodium valproate resulted in a five-fold increase in the risk of congenital abnormalities or developmental disabilities. The ANSM said that it had been working for several years to limit use of sodium valproate in women of childbearing age but will cooperate with the judicial process. Sanofi noted that "drug companies cannot unilaterally change information documents without the permission of national health authorities" and said it had asked for changes to sodium valproate product information. Dyer O. France’s drug regulator is indicted for manslaughter over sodium valproate birth defects. BMJ : 13 Nov 2020. Available from: URL: https://www.bmj.com/ content/371/bmj.m4446
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Reactions 21 Nov 2020 No. 1831
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