Epilim® (valproate) - Risk of congenital malformations and serious developmental disorders in children exposed in utero to valproate

Sanofi-Aventis has issued an annual reminder to inform healthcare professionals of the risk of congenital malformations and serious developmental disorders in children who are exposed in utero to Epilim^®. As children exposed in utero to valproate are at a high risk of serious developmental disorders and/or congenital malformations, valproate should not be prescribed to female children, female adolescents, women of child-bearing potential or pregnant women unless other treatments are ineffective or not tolerated. Valproate treatment must be started and supervised by a specialist experienced in managing epilepsy or bipolar disorder. Healthcare professionals are advised to carefully balance the benefits of valproate treatment against the risks when prescribing valproate for the first time, at routine treatment reviews, when a female child reaches puberty and urgently when a woman plans a pregnancy or becomes pregnant. Female patients must be informed of and understand the risks associated with valproate during pregnancy, the need to use effective contraception and for regular review of treatment, and to rapidly inform the physician if she is planning a pregnancy or becomes pregnant. The local package insert has been updated with warnings on risks of valproate use during pregnancy. Please refer to the letter for details.