Sodium valproate

Amber-G

Brand Name(s):Epilim

Indication:Anticonvulsant

Rationale:

Considered:Sep-18

Review Date:Sep-23

Comments:
Jan 20 – Prescribers are now advised that in utero exposure to valproate may also result in hearing impairment or deafness in the child due to ear and/or nose malformations and/or to direct toxicity on the hearing function. When outcomes were reported, the majority of the cases did not recover.
UKMI comment; Valproate is contraindicated as treatment for epilepsy during pregnancy unless there is no suitable alternative to treat epilepsy.  It is also contraindicated for use in women of childbearing potential unless the conditions of the Pregnancy Prevention Programme are fulfilled (See SPC for advice). LINK; https://www.medicinesresources.nhs.uk/en/Medicines-Awareness/Guidance-and-Advice/Drug-Prescribing/Revised-SPC-sodium-valproate-valproate-semi-sodium-and-valproic-acid-products/