Update on 2 specialist review requirements for male patients already taking valproate
Published 13 February 2025
Audience: Healthcare professionals
Summary
The MHRA is reinforcing the requirement for all male patients, of any age, who are prescribed valproate to have regular specialist reviews to assess the risks and benefits of continued treatment. They should also be counselled about the risks of valproate exposure in utero.
Action
- Ensure that male patients on valproate are receiving regular specialist reviews. This includes counselling them on the potential risks and benefits of valproate, and the risk of valproate exposure in utero.
- Refer all male patients on valproate to a specialist.
- Consider alternative treatment options for all male patients, including stopping valproate.
Background
Valproate is an anti-epileptic medicine used to treat epilepsy and bipolar disorder. It is also used to prevent migraines.
Valproate is known to cause birth defects in children who are exposed to it in the womb. These defects can include spina bifida, cleft lip and palate, and heart defects.
The MHRA has previously recommended that valproate should not be used in women of childbearing potential unless other treatments are not suitable. For more information on this recommendation, see below:
Specialist review requirements
As well as stopping the use of valproate during pregnancy, the MHRA is also requiring all male patients, of any age, who are prescribed valproate to have regular specialist reviews to assess the risks and benefits of continued treatment.
These reviews should be carried out by a doctor who is experienced in treating epilepsy or bipolar disorder. The doctor should:
- Discuss the risks of valproate exposure in utero with the patient.
- Consider the patient’s individual circumstances and whether there are any alternative treatment options that would be more appropriate.
- Decide whether to continue prescribing valproate and, if so, how often the patient should be reviewed.
Alternative treatment options
There are a number of alternative treatment options available for epilepsy and bipolar disorder. These options include other anti-epileptic medicines, mood stabilisers, and psychological therapies.
The doctor should discuss the alternative treatment options with the patient and help them to decide which option is the most appropriate for them.
Reporting adverse reactions
Healthcare professionals are asked to report any suspected adverse reactions to valproate to the MHRA.
Further information
- Valproate: background information on the medicine
- MHRA guidance on the use of valproate in women of childbearing potential
- Epilepsy Action
- Bipolar UK
Update on 2 specialist review requirements for male patients already taking valproate
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