MHRA bans valproate without pregnancy prevention programme

Medical Devices

Valproate, available on the UK market as Epilim, Depakote and generic brands, is an effective treatment for epilepsy and bipolar disorder. However there are significant risks associated with the drug, with around 10% of children born to women who take the drug during pregnancy being at risk of birth defects. The Medicines and Healthcare products Regulatory Agency has changed its licence so it can only be prescribed to female patients of child-bearing age who are enrolled in the pregnancy prevention programme (PPP), which requires the patient to sign a risk acknowledgement form when their treatment is reviewed, which happens at least once year.

“Patient safety is our highest priority. We are committed to making sure women and girls are aware of the very real risks of taking valproate during pregnancy. However, we also know it is vitally important women don’t stop taking valproate without first discussing it with their doctor,” noted Dr June Raine, director of MHRA’s Vigilance and Risk Management of Medicines Division.

“10% of children born to women who take the drug Epilim during pregnancy being at risk of birth defects.“

Ash Soni, president of The Royal Pharmaceutical Society, said: “The RPS fully supports these new measures implemented today by the MHRA to ensure women understand the risks of taking sodium valproate during pregnancy. They must get the right information from health professionals in order to make informed choices about their health and parenting options,”

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