New Valproate safety measures

by | Feb 20, 2024 | Blog, MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) announced that from the 31st of January 2024 new regulatory measures have been implemented to ensure that the known harms associated with valproate use are reduced.

Other effective treatment options are available for the majority of patients. However, use of valproate must not be started in new patients under the age of fifty-five, unless it has been documented that two specialists have independently considered that no alternative effective/ tolerated treatment is available or if it has been demonstrated that the reproductive risks are not applicable.

A revised valproate Annual Risk Acknowledgement Form will be used to review treatment for all women and girls who are currently using valproate at their next annual specialist review, which will include the need for a secondary specialist’s independent opinion and signature.

To support the implementation of these measures new safety and educational materials have been introduced for patients and healthcare professionals. Clinicians should endeavour to ensure that current warnings and upcoming measures relating to valproate use are discussed with their patients and consideration should be given to the effects on the patient’s individual circumstances.

No one should stop taking valproate without their healthcare professionals’ advice

For further information follow the link to the news story below:

https://www.gov.uk/government/news/new-valproate-safety-measures-apply-from-31-january

For further information on press release by the MHRA regarding new measures to reduce ongoing serious harms of valproate follow the link below:

https://www.gov.uk/government/news/mhra-instructs-health-organisations-to-prepare-now-for-new-measures-to-reduce-ongoing-serious-harms-of-valproate

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