Changes to valproate use following safety concerns

On 28th November 2023 a national patient safety alert was issued after the Medicines and Healthcare products Regulatory Agency (MHRA) published new measures for the use of valproate.

Covering the use of sodium valproate, valproic acid and valproate semisodium, new measures will significantly reduce the use of the drug due to known risks including serious harm to infants exposed in pregnancy and impact on male fertility. Predominantly used in people with epilepsy, the drug is known to be prescribed to people with migraine as well.

Healthcare providers are being asked to put plans in place across a two-phased approach to reducing use. Phase 1 must begin from 31st January this year.

Phase 1

From 31st Jan 2024:

No new patient under the age of 55, regardless of gender, may begin use of the drug unless two specialists confirm it is the only suitable option available for that individual.

Any female under the age of 55 currently being prescribed valproate must be reviewed using a revised valproate Risk Acknowledgement Form, which will include the need for a second specialist signature if the patient is to continue with valproate (Nov 2023).

For the latter group, the WHO's statement that advice on effective contraception must be given for the duration that valproate is used, and that every effort to switch treatment must be made if that individual is considering becoming pregnant are also useful to add (May 2023).

Phase 2

From later in 2024, any male under the age of 55 currently being prescribed valproate must be reviewed for appropriateness of treatment, with further specific guidance on assessment forms and parameters for continuation expected to follow later in the year.

The ABN have issued helpful guidelines to support healthcare providers, prescribers and associated professionals detailing the implementation of phase 1, including accepted signatories and the process needed to continue valproate use in a female currently being prescribed it.

Alternate medications for use in all new patients and to support switching for existing female patients in line with phase 1 action are also listed in the guidelines.

For more information, read the safety alert or for practical support in implementing phase 1, please see the guidance.