NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Medicines Update

Valproate and risk of abnormal pregnancy outcomes: new communication materials

In January 2015, the Medicines and Healthcare products Regulatory Agency (MHRA) published information and strengthened warnings around the safety of medicines related to valproate (sodium valproate, valproic acid and valproate semisodium). Children exposed to valproate in utero are at high risk of developmental disorders and congenital malformations. Refer to the Medicines Update blog published last year for further information.

In February 2016, the MHRA issued further information to improve awareness.

What’s new?

New communication materials are now available to use with female patients when prescribing valproate. Healthcare professionals are advised to use the new communication materials to support discussion of the risks with women of childbearing potential and girls who take valproate.

The materials consist of:

• A booklet for healthcare professionals

• A consultation checklist

• A patient guide

• A patient card

All materials can be ordered directly from Sanofi by calling 0845 372 7101.

Key messages for healthcare professionals

Specialists (neurologists, psychiatrists, paediatricians)

• Read the healthcare professional booklet which provides a comprehensive overview of the risks of valproate in females of childbearing potential and during pregnancy, points to consider and steps to take when deciding to treat women of childbearing potential and girls with valproate.

• If valproate is prescribed, use the consultation checklist to ensure patients have understood all the necessary information. Add the completed checklist to patients’ medical notes.

• If valproate is prescribed, provide patients with the patient guide and ensure they understand the information within it.

• Paediatricians should refer parents or carers to the Royal College of Paediatrics and Child Health information about valproate (via http://www.medicinesforchildren.org.uk/sodium-valproate-preventing-seizures).



• Do not initiate valproate in this patient group. Valproate should be started and supervised by a specialist experienced in managing epilepsy or bipolar disorder.

• Consider the need to arrange treatment reviews with the relevant specialist for women of childbearing potential and girls who are currently taking valproate.

• If a woman who is taking valproate tells you she is pregnant or would like to have a baby, refer her to the specialist responsible for her care.



• Supply a patient card to women of childbearing potential and girls when dispensing valproate unless they can confirm they already have a card.

• Where possible, encourage patients or parents/carers to read the card and enter the patient’s name and date of issue.

• Cards can be ordered directly from Sanofi by calling 0845 372 7101.