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Table 3 Measures to Avoid VPA Exposure During Pregnancy; Summary of EMA guidance from the Pharmacovigilance Risk Assessment Committee

From: Diagnosis and management of individuals with Fetal Valproate Spectrum Disorder; a consensus statement from the European Reference Network for Congenital Malformations and Intellectual Disability

1 VPA must not be used for treatment of migraine or bipolar disorder during pregnancy
2 VPA must not be used to treat epilepsy during pregnancy unless there is no other effective treatment available. Women requiring VPA treatment should be supported and counselled
3 VPA should not be prescribed to any girl or woman able to have children unless she is on a Pregnancy Prevention Programme. This will include an assessment of potential to become pregnant, pregnancy tests before starting and during treatment, counselling about the risks of VPA treatment and the need for effective contraception whilst on treatment, review of treatment by a specialist at least annually and signing of a risk acknowledgement form
4 Women and girls who have been prescribed valproate should not stop taking their medicine without consulting their doctor as doing so could result in harm to themselves or to an unborn child.