A recent European review found that up to 40 per cent of children born to women who take valproate during pregnancy may have developmental disorders. The MHRA is therefore urging healthcare professionals to give women better information about valproate’s risks.

Information booklets will educate healthcare professionals and patients, while patient information leaflets will carry stronger warnings about developmental disorders, in addition to the birth defects in children exposed to valproate during pregnancy.

“If valproate is the only option, women of childbearing age should be given effective contraception. Women taking valproate must have regular reviews of their treatment,” says June Raine, director of MHRA’s vigilance and risk management of medicines division. “However it is important that no-one should stop taking valproate without discussing it first with their doctor.”