2 April 2019

NICE Publishes a Summary of Its Guidance and Other Safety Advice on Valproate

NICE has today (28 March) published a summary for healthcare professionals bringing together all its recommendations and other safety advice on the drug valproate.

Valproate is licensed for use in epilepsy and bipolar disorder. It is also used off-label for depression, neuropathic pain, dementia and migraine.

Children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders. If valproate is taken during pregnancy, up to 4 in 10 babies are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects.

Publication of NICE’s summary on valproate follows the strengthening last year of restrictions on its use by the Medicines and Healthcare products Regulatory Agency (MHRA). This effectively banned its use for women of child bearing potential unless they are on a pregnancy prevention programme (PPP).

The NICE summary sheet on valproate brings together existing information and advice on safe prescribing from other sources (for example, MHRA safety alerts, BNF information, summary of products data and information from the Driver and Vehicle Licensing Agency) with NICE’s existing guideline recommendations, to produce easy to access, practical recommendations supported by a visual summary.

Paul Chrisp, director of the Centre for Guidelines at NICE, said: “We worked closely with the MHRA to ensure that our guidelines which mention valproate were amended last year in order to signal the need for clinical practice to align with their revised regulatory position on valproate.

“This summary is a continuation of that work. It recognises the importance of a single cross-disciplinary valproate guideline to support healthcare professionals from all disciplines in the safe use of valproate and it will help to ensure that children are not exposed to valproate through their mother during pregnancy.”