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UK Bans Birth Defect-Linked Sanofi Drug for Women of Childbearing Age
Drugs Postmarket Safety
The UK banned the use of a Sanofi drug for bipolar disorder and epilepsy by women or girls of child-bearing age without a pregnancy prevention plan after reports of birth defects.
Valproate, which is sold as Depakine for epilepsy and Depakote and Depamide for bipolar disorder, received a European recommendation for stricter controls last month.
Eligible women in the U.K. may only take the drug if they take contraception throughout treatment, undergo pregnancy testing and sign a form acknowledging they understand the risks.
Between its 1967 approval in France and 2016, the drug is believed to have caused serious birth defects in up to 4,100 French children.