UK – 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…