THE UK Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licence for valproate medicines (Epilim, Depakote and generic brands) so that it must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention program.
Valproate is a treatment for epilepsy and bipolar disorder.
Children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders - if valproate is taken during pregnancy, up to 40% of babies are at risk of developmental disorders, and approximately 10% are at risk of birth defects.
Pregnancy is a contraindication for valproate in Australia.
The Australian PI is available at ebs.tga.gov.au.
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