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The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended new measures to prevent exposure of babies to valproate medicines in the womb.1 An earlier initiative had been aimed at helping women to become better informed about the risks in order to reduce use of valproate medicines during pregnancy, and not starting treatment unless other options were ineffective or could not be used because of adverse effects. The latest review of safety measures comes after concerns were raised that the previous initiative had not been been not sufficiently effective.
PRAC reviewed the evidence and consulted with healthcare professionals and with patients, …