Statement by Gail Caldwell, Director of Pharmacy
Sodium valproate is an effective medicine used to treat epilepsy and bipolar disorder.
Since its introduction in 1974, the product information has included a warning about the possible risk of birth defects. As the risks to unborn children have been increasingly understood, the warnings have been strengthened.
NHS Ayrshire & Arran follows the current national advice that sodium valproate should not be used in female children, in female adolescents, in women of childbearing potential and in pregnant women unless other treatments are ineffective or not tolerated. The medicine should now only be started by a specialist. If sodium valproate is the only effective option for a woman of childbearing age then they must always be given effective contraception.
MHRA (The Medicines and Healthcare Products Regulatory Agency) is the body with responsibility for the regulation of medicines in the UK. It operates a Yellow Card Scheme, which monitors the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those that use them. It has worked with industry, healthcare professionals and patient groups on a toolkit to ensure female patients are better informed about the risks of taking sodium valproate medicines during pregnancy.
Anyone who is currently taking sodium valproate and has not had a recent review or has any concerns about taking it should contact their GP (Family Doctor) for medical advice before taking any action. No-one should stop taking sodium valproate without discussing it first with their doctor. The correct process must be followed to safely withdraw from the drug and seek an appropriate alternative without causing harm.
If you experience any side effects with any drug, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.