MHRA issues alert for valproate
Our clinical supervisor Krystle Banfield on the MHRA alert for Valproate.
Valproate is licensed in the UK for treatment of epilepsy and bipolar disorder (mania or continuation of treatment following manic episode).
Due to the risks of using in pregnancy (these babies have an 11% risk of birth defects and a 30-40% risk of neuro-developmental disabilities which can be permanent), it should be avoided in female children and women of child-bearing potential, unless other treatments are ineffective or not tolerated. Where treatment is needed, women of child-bearing potential should be enrolled on a Pregnancy Prevention Programme which includes the requirement of effective contraception. Understandings of risks should be documented and reviewed yearly using an annual risks acknowledgement form.
At each dispensing of valproate, information should be provided to highlight these risks.
Although prescribing of valproate in pregnant women has fallen to a quarter of those prescribed in 2017-2018, the MHRA conducted a review of the available data and asked for advice from the independent Commission on Human Medicines (CHM), following concerns that the guidelines were not being followed. There are also concerns of possible reduced fertility in males taking valproate (reversible on dose reduction or discontinuation).
“The CHM has advised that no one under the age of 55 should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment. Where possible, existing patients should be switched to another treatment unless two specialists independently consider and document that there is no other effective or tolerated treatment or the risks do not apply”.
From January 2024, the MHRA is asking organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semisodium (valproate). This includes:
“A. 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.
B. At their next annual specialist review, women of childbearing potential and girls should be reviewed using a revised valproate Risk Acknowledgement Form, which will include the need for a second specialist signature if the patient is to continue with valproate and subsequent annual reviews with one specialist unless the patient’s situation changes.”
Find out more about this guideline, through the following links:
Update on MHRA review into safe use of valproate – GOV.UK (www.gov.uk)
Valproate safety measures – GOV.UK (www.gov.uk)
Read through some of our other resources here: Ashtons Resources – Improving quality and compliance in medicines management
Updated NICE Guideline CG185 – ‘Bipolar disorder: assessment and management’ – Ashtons
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