New valproate safety measures in the UK

Excerpt

New regulatory measures to reduce the harms from valproate have been put in place by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.The new safety measures have been put in place to reduce the significant risk of serious harm to the baby if valproate is taken during pregnancy. There is also the risk of impaired fertility in males. The new valproate safety measures apply from 31 January 2024. These important regulatory changes have been recommended by the Commission on Human Medicines to increase scrutiny of valproate prescribing in order to reduce the harms from this agent.From 31 January 2024, valproate must not be started in new patients (male or female) younger than 55 years unless two specialists independently document that there is no other effective or tolerated treatment, or that the reproductive risks do not apply. Women and girls who are currently taking valproate and who could become pregnant should be reviewed at their next annual specialist visit. At this visit, et al. revised valproate Annual Risk Acknowledgement Form should be used. If the patient is to continue with valproate treatment, the signature of a second opinion is required. New safety and educational materials have been introduced for healthcare professionals and patients to support the new regulatory measures. Healthcare professionals have been advised to review the new measures and materials. Healthcare professionals should discuss the upcoming measures relating to valproate with their patients. Patients have been advised to attend any offered appointments to discuss their treatment plan, and they should talk to their healthcare professionals if they have any concerns. However, no one should stop taking valproate without advice from their healthcare professional. …