Update on 2 specialist review requirements for male patients already taking valproate
13 February 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding healthcare professionals about 2 specialist review requirements for male patients already taking valproate.
Valproate is an anti-epileptic medicine that is also used to treat bipolar disorder. It is important to note that valproate must not be used in girls and women of childbearing potential unless other treatments are ineffective or not tolerated.
The 2 specialist review requirements for male patients already taking valproate are:
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All male patients taking valproate should have a specialist review at least once a year by a healthcare professional with experience in managing epilepsy or bipolar disorder. This review should include an assessment of the benefits and risks of continuing treatment with valproate, and a discussion of alternative treatment options.
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Male patients taking valproate who are planning to father a child should have a specialist review before they start trying to conceive. This review should include a discussion of the risks of valproate to the baby, and a discussion of alternative treatment options.
These specialist review requirements are in place to help ensure that male patients taking valproate are receiving the best possible care.
The MHRA is also reminding healthcare professionals that valproate must not be used in:
- Girls and women of childbearing potential unless other treatments are ineffective or not tolerated.
- Boys and men under the age of 18 years with bipolar disorder.
Healthcare professionals should also be aware of the signs and symptoms of valproate-induced liver injury, which can be serious and can lead to liver failure.
For more information, please see the MHRA’s drug safety update on valproate.
Additional information
Valproate is a prescription-only medicine. It is available as tablets, capsules, a liquid, and an injection.
Valproate is used to treat:
- Epilepsy
- Bipolar disorder
Valproate works by reducing the number of seizures in people with epilepsy. It also helps to stabilize mood in people with bipolar disorder.
Valproate can cause side effects, including:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Headache
- Dizziness
- Tremor
- Weight gain
- Hair loss
Valproate can also cause serious side effects, including:
- Liver damage
- Pancreatitis
- Bone marrow suppression
- Birth defects
It is important to talk to your doctor about the risks and benefits of taking valproate before starting treatment.
If you are taking valproate, it is important to:
- Take your medicine exactly as directed by your doctor.
- Do not take more or less medicine than prescribed.
- Do not stop taking your medicine without talking to your doctor.
- Tell your doctor if you have any side effects.
- Tell your doctor if you are planning to become pregnant or if you are pregnant.
- Tell your doctor if you are breastfeeding.
For more information, please see the MHRA’s website.
Update on 2 specialist review requirements for male patients already taking valproate
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