As the European Commission considers whether to introduce a partial ban on use of the epilepsy drug valproate in pregnancy over risks to unborn babies, researchers in The BMJ discuss the arguments and the implications for patients and healthcare professionals.
Valproate is an effective treatment for epilepsy, bipolar disorder and migraine. For some women with epilepsy, it may be the only effective treatment option.
But the drug carries a 10% chance of causing physical abnormalities and a 30-40% risk of developmental problems such as autism and developmental delay in children born to mothers who take it. In the UK alone, around 20,000 children have been harmed since valproate was introduced in the 1970s.
Earlier this year, the European Medicines Agency recommended that valproate should not be used in pregnancy unless the woman has epilepsy that has not responded to alternative medications. It should not be prescribed to women of childbearing age unless they use contraception. But surveys show that many women with epilepsy are still unaware of the risks.
Responses from expert advisory groups and regulators have varied, from those advocating shared decision making and informed patient choice about taking valproate in pregnancy, to restricted use when other treatments have failed, to prohibition of valproate in pregnancy coupled with a pregnancy prevention programme in all women taking it.
Consultant neurologists Heather Angus-Leppan and Rebecca Liu say, despite international consensus on the harmful effects of valproate during pregnancy, its use may be warranted in certain situations.
In a linked editorial, consultant perinatal psychiatrists Angelika Wieck and Sarah Jones explain that, if the European Commission accepts the recommendations, all women of childbearing age who are being prescribed valproate will require regular review and must follow a pregnancy prevention programme.