Valproate safety measures
Collection of information and guidance for patients and for healthcare professionals on the reproductive risks of valproate and new safety measures introduced to reduce these risks.
Information about valproate
Valproate-containing medicines are sodium valproate, valproic acid and valproate semisodium, so you may see these words on the box. These medicines are used in some patients with epilepsy and bipolar disorder. Products may also be referred to using various brand names which include Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell.
If you are concerned about the risks of valproate, talk to your doctor, nurse, pharmacist or another healthcare professional.
No one should stop taking valproate without advice from a specialist because of the importance of keeping their condition under control.
Safety and educational materials
On 28 November 2023 we asked health organisations to prepare now for new measures to reduce ongoing serious harms of valproate. These were introduced in January 2024.
We ask patients to attend any offered appointments to discuss their treatment plan and to talk to a healthcare professional if they are concerned.
We ask clinicians to discuss the current warnings and introduced measures relating to valproate with their patients and consider together how it affects the patient’s individual circumstances.
To support the implementation of these measures for valproate, the following safety and educational materials are available:
- Patient guide: Provides those taking valproate (or their parent, caregiver, or responsible person) with information on the risks of valproate in pregnancy and the risks to male patients and what they need to do.
- Healthcare Professional Guide: Provides updated information for healthcare professionals on the risks of valproate in pregnancy and the risks for male patients, the new conditions for valproate prescribing and key points for patient discussions.
- Annual Risk Acknowledgement Form: For female patients starting valproate and at annual review. Used to support and record the discussion between the patient and specialist prescriber on the risks associated with valproate in pregnancy and to record the decision of the countersigning specialist. At subsequent annual reviews only one specialist is required.
- Risk Acknowledgement Form for male patients starting valproate: Used to support and record the discussion between the patient and specialist prescriber of the risks associated with valproate in males when starting treatment with valproate and to record the decision of the countersigning specialist. This is only to be completed at initiation of valproate.
- Patient card: Provides key information for female patients receiving valproate on contraception and pregnancy prevention.
- Pharmacy poster: Provides important actions for pharmacists dispensing valproate to female patients.
- Warning stickers: To be added to packaging of medicine in exceptional circumstances where the original pack cannot be dispensed.
See Product Information for valproate medicines, including the Patient Information Leaflet.
Precautionary advice for men taking valproate
In September 2024 we advised men taking valproate and their partners to use effective contraception because of new data suggesting a potential small increased risk of harm to children if valproate is used by a father around the time of conception. Further advice is available in our Drug Safety Update.
Updates will be made to the safety and educational materials above in the coming months.
Guidance
Updates to this page
Last updated 5 September 2024 + show all updates
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Updated guidance to include latest information on Paternal exposure to Valporate
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Added safety and educational materials (Patient guide, Healthcare Professional Guide, Annual Risk Acknowledgement Form, Risk Acknowledgement Form for male patients starting valproate, Patient card, Pharmacy poster, Warning stickers)
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First published.