New valproate safety measures apply from 31 January
No one should stop taking valproate without advice from their healthcare professional
From today [31 January 2024], new regulatory measures are in place to reduce the known harms from valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males.
Healthcare organisations were instructed by the Medicines and Healthcare products Regulatory Agency (MHRA) on 28 November to put in place a plan to prepare for these changes.
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 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.
These are important regulatory changes recommended by the Commission on Human Medicines to increase scrutiny of valproate prescribing to reduce the harms from valproate.
New safety and educational materials have been introduced for patients and healthcare professionals to support the implementation of these measures. The MHRA has asked healthcare professionals to review the new measures and materials and integrate them into their clinical practice when referring patients and to aid in discussion with patients concerning treatment with valproate.
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.