The medicines regulator has asked healthcare organisations to plan for new measures related to the anti-seizure medication valproate. These changes will start to be rolled out from January 2024.
No one should stop taking valproate without advice from a specialist.
MHRA instructs health organisations to prepare now for new measures to reduce ongoing serious harms of valproate
Other effective medicines are available for epilepsy and bipolar disorder and valproate should only be used if these don’t work or aren’t suitable for an individual patient
Healthcare organisations are being instructed by the Medicines and Healthcare products Regulatory Agency (MHRA) now to put in place a plan to implement the first phase of new regulatory measures to reduce the known harms of valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males.
From January 2024, 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 unless there are compelling reasons that the reproductive risks do not apply. For the majority of patients, other effective treatment options are available.
All women who could become pregnant and girls who are currently taking valproate will be reviewed at their next annual specialist review, using a revised valproate Annual Risk Acknowledgement Form, which will include the need for a second opinion’s signature if the patient is to continue with valproate.
A similar system will be introduced later in 2024 for male patients currently taking valproate. This follows advice from an independent expert group of the Commission on Human Medicines, with representation from across the healthcare system, that the measures should be introduced in a phased manner to ensure ongoing patient care is not disrupted.
These are important regulatory changes recommended by the Commission on Human Medicines to increase scrutiny of valproate prescribing and ensure that valproate is only used when the benefits outweigh the risk.
The MHRA urges patients to attend any offered appointments to discuss their treatment plan and to talk to a healthcare professional if they are concerned.
Clinicians should discuss the current warnings and upcoming measures relating to valproate with their patients and consider together how it affects the patient’s individual circumstances.
Dr Alison Cave, MHRA Chief Safety Officer said:
“Valproate use in pregnancy carries significant risk of harm to the unborn child and should only be used in girls and women of child-bearing potential if a pregnancy prevention programme is in place. It also carries a risk of impaired fertility in males.
“To better protect patients from these harms, we are taking robust regulatory action to ensure greater scrutiny of valproate prescribing. Valproate should only be used when no other treatment is effective.
“If you are a patient on valproate, we ask you to attend any appointments offered over the next year to discuss your treatment plan. Please talk to a healthcare professional if you are concerned.
“No one should stop taking valproate without advice from their specialist.”