UK Bans Birth Defect-Linked Sanofi Drug for Women of Childbearing Age

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.