Valproate Semi-Sodium

Red

Brand Name(s):Depakote Belvo

Indication:Acute mania associated with bipolar disorder

Rationale:1

Considered:Oct-08

Review Date:Sep-24

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/

Drug Safety Update
Valproate medicines (Epilim, Depakote): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met
Apr 2018
Drug Safety Update
Valproate and developmental disorders: new alert asking for patient review and further consideration of risk minimisation measures
April-22
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Drug Safety Update
Medicines related to valproate: risk of abnormal pregnancy outcomes
Jan 2015