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.
