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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Valproate Precaution In Men

The MHRA has issued advice ahead of the September issue of the Drug Safety Update advising that men taking valproate use effective contraception throughout the valproate treatment period and for three months after stopping valproate. This recommendation has been reported in the general media (BBC).

This advice is based on the results of a retrospective observational study that has indicated a possible association between valproate use by men around the time of conception and an increased risk of neurodevelopmental disorders in their children. It is recommended that men on valproate are informed of this new recommendation at initiation of treatment and at reviews. Effective contraception is recommended, specifically condoms, plus contraception used by the female sexual partner, and they should not donate sperm during valproate treatment and for three months after stopping. This three month window allows for one completed sperm cycle while not exposed to valproate. At routine reviews, men on oral treatment should be asked if they are planning a family in the next year and if they are, a referral to a specialist to discuss alternative treatment options should be made.

Action: Clinicians should be aware of this new guidance and implement the recommended changes to practice.

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