A reminder advisory has been issued for healthcare professionals by Britain’s Medicines & Healthcare Products Regulatory Agency regarding valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival and Syonell).
Review by two specialists remains in place for all patients initiating valproate under 55 but the Commission on Human Medicines (CHM) has advised that this will not be required for men (or males) currently taking valproate.
Given the recent recommendations in the September 2024 update, the CHM said there was already sufficient risk minimisation in place for this patient group but that this position should be kept under review.
Valproate is authorised for the treatment of epilepsy and bipolar disorder, but has potential risks of major congenital malformations or neurodevelopmental disorders in children when mothers take it during pregnancy.
More recently, the risk of a range of neurodevelopmental disorders in children born to fathers taking valproate compared with other anti-seizure medicines was described.
In 2022, the CHM reviewed the latest data on the reproductive risks with valproate, their advice being communicated in Drug Safety Update December 2022. The CHM formed an implementation group to advise on the safe introduction of the new measures into clinical practice.
The measures were applied first to all new patients under 55 and women of childbearing potential already under specialist review. A National Patient Safety Alert on 28 November 2023 and Drug Safety Update January 2024 provided further advice on implementation of these requirements.
No requirement for specialist review of men currently taking valproate was introduced at this time unless the male patient was planning to father a child.
See more from MedicalBrief archives:
Another Valproate alert over risks of children’s disorders
Valproate treatment rules tightened over children’s disorder risk
Sanofi ordered to compensate for epilepsy drug’s autism side-effect in pregnancy