French health prod­ucts agency yanked in­to le­gal bat­tle over birth de­fects caused by Sanofi's De­pakine

A probe in­to Sanofi’s epilep­sy drug De­pakine has now en­tan­gled France’s Na­tion­al Med­i­cines and Health Prod­ucts Agency (ANSM), which was in­dict­ed on Wednes­day for “in­juries and manslaugh­ter by neg­li­gence” re­lat­ed to birth de­fects and still­born births caused by the drug.

Sanofi found it­self at the cen­ter of a manslaugh­ter in­ves­ti­ga­tion in Au­gust, sev­er­al months af­ter it was for­mal­ly charged. The drug, sodi­um val­proate, has been on the mar­ket since 1967 for epilep­sy and bipo­lar dis­or­der. It’s on the WHO’s list of “es­sen­tial med­i­cines,” and is pre­scribed in over 100 coun­tries. But ac­cord­ing to Reuters, France’s so­cial af­fairs in­spec­tion agency es­ti­mates 425 to 450 ba­bies ex­posed to the drug suf­fered con­gen­i­tal birth de­fects or were still­born from 2006 to 2014.

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