Too slow to warn: Sanofi in­dict­ed over old an­ti-epilep­tic drug tied to birth de­fects

Sanofi has been for­mal­ly charged over De­pakine — a decades-old ther­a­py for epilep­sy that caus­es birth de­fects and im­pedes neu­ro­log­i­cal de­vel­op­ment when tak­en dur­ing preg­nan­cy.

Ev­i­dence that the com­pound — sodi­um val­proate — was as­so­ci­at­ed with neu­rode­vel­op­men­tal risks emerged in the lat­ter half of the 20th cen­tu­ry. In 2014, the EMA re-eval­u­at­ed the drug, and a year lat­er rec­om­men­da­tions that prac­ti­tion­ers should no longer pre­scribe the treat­ment for women of child­bear­ing age or preg­nant women were en­forced.

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