- BNF:
- 4.2.3
- Status:
- Green - after consultant/specialist initiation, Green - after consultant recommendation
- Decision Date:
- August 2013
Comments
NPSA
November 2023; MHRA
January 2024 Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim,
Epilim Chrono or Chronosphere, Episenta, Epival, and Syonellâ–¼): new safety
and educational materials to support regulatory measures in men and women
under 55 years of age.
- valproate must not be started in new patients (male or female)
younger than 55 years, unless two specialists independently consider and
document that there is no other effective or tolerated treatment, or
there are compelling reasons that the reproductive risks do not apply.
For the majority of patients, other effective treatment options are
available.
- at their next annual specialist review, women of childbearing
potential and girls receiving valproate should be reviewed using the
revised valproate Annual Risk Acknowledgement Form. A second specialist
signature will be needed if the patient is to continue on valproate,
however subsequent annual reviews will only require one specialist.
- general practice and pharmacy teams should continue to prescribe and
dispense valproate and if required offer patients a referral to a
specialist to discuss their treatment options. Valproate should be
dispensed in the manufacturer’s original full pack
Reminder by MHRA December 2022, MHRA 2021, MHRA 2020,February 2016, MHRA January 2015. Valproate: risk of abnormal pregnancy outcomes.
Women and girls of childbearing potential must comply with Pregnancy Prevention Programme - toolkit.
GREEN after consultant/specialist initiation: for epilepsy
GREEN after consultant recommendation: for mania
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