The Medicines and Healthcare products Regulatory Agency (MHRA) has published a drug safety update for valproate use in men.

A retrospective observational study 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. Inform male patients who may father children of this possible increased risk and the recommendation to use effective contraception during valproate treatment and for at least 3 months after stopping valproate.

See a previous Drug Safety Update for the introduction of the prescribing requirements in all patients under 55 years of age (female and male) – the new advice provided here is in addition to these measures.

No one should stop taking valproate without talking to their healthcare professional.

Further information can be found on the MHRA website, this includes:

• Information and advice for healthcare professionals
• Information and advice for healthcare professionals to provide to patients
• Review of data regarding potential risk to children with paternal use of valproate.
• Information about the study findings
• Proposed mechanism of action of paternal transmission

The MHRA has also produced Advice for male patients on valproate to use contraception and visual risk communication diagram to be used by a healthcare professional when counselling on the risks