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Editorials

Dangers of valproate in pregnancy

BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k1609 (Published 18 April 2018) Cite this as: BMJ 2018;361:k1609
  1. Angelika Wieck, honorary consultant perinatal psychiatrist,
  2. Sarah Jones, consultant perinatal psychiatrist
  1. Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK
  1. Correspondence to: A Wieck: angelikawieck73{at}gmail.com

New measures expected to improve protection for unborn children

In the UK, valproate is licensed for the treatment of all forms of epilepsy and manic episodes in bipolar disorder when lithium is contraindicated or not tolerated. In patients whose manic symptoms have responded, valproate can be continued to prevent recurrence. In practice, valproate is also prescribed for unlicensed indications, including prophylaxis against migraine, prevention of clozapine induced seizures, and reduction of aggression, impulsivity, and other symptoms in adults with severe mental disorders.

On 9 February this year, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency1 published its recommendation that valproate should not be used in pregnancy unless the woman has a form of epilepsy that is unresponsive to other anti-epileptic drugs. The committee also recommended that the drug should not be prescribed to patients with childbearing potential unless they follow a comprehensive “pregnancy prevention programme.” These recommendations, which go further than previous European and UK guidance, were adopted by the Coordination Group for Mutual Recognition and Decentralised …

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