General Practice Actions for The Safe Use of Valproate in Men within NEL

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Valproate (sodium valproate, valproic acid and valproate semisodium) is primarily used in epilepsy and bipolar disorder. It is also used outside of the license (‘off label’) to treat other conditions. Valproate is subject to a national patient safety alert due to significant risk of harm to babies upon exposure during pregnancy. New evidence has shown a possible association between valproate use in men at conception with increased risk of neurodevelopmental disorders in children.

Due to new of evidence of possible harms of valproate in men, the MHRA has issued new safety measures to further support prescribers around the safe use of valproate in all men and their partners.

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