Valproate semi-sodium

Amber-G

Brand Name(s):Depakote

Indication:Bipolar Disorder management of stable condition

Rationale:

Considered:Jan-08

Review Date:Apr-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/

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
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Updated NICE CG185 February 2016

Drug Safety Update
Jan 2015

NICE CG 185
September 2014

Guidance for the ongoing prescribing of AED’s as mood stabilisers for stable bipolar disorder can be found at:http://medicinesmanagement.doncasterpct.nhs.uk/ under guidance- local
May 2014

Drug Safety Update Volume 3 Issue 10 May 2010