Women taking valproate should be told about the risks of developmental disorders in children exposed to the drug during pregnancy, says the UK medicines regulator.
The call follows the strengthening of product information for valproate-containing medicines after a 2014 European review found that up to 40% of children born to women who take valproate during pregnancy may have such disorders, including delayed walking and talking, memory problems, difficulty with speech and language and lower intellectual ability.
“We want to ensure that medical professionals inform women and girls of the latest information about the risks of developmental disorders in children exposed to valproate during pregnancy, in addition to the already well-known risks of birth defects,” says June Raine, director of the Medicines and Healthcare products Regulatory Agency’s vigilance and risk management of medicines division.
In line with advice from the European Medicines Agency, the MHRA says that if valproate is the only treatment option, women of childbearing age should be given effective contraception. Women taking valproate must also have regular reviews of their treatment.