The Medicines and Healthcare Products Regulatory Agency (MHRA), Britain’s drug regulatory agency, has issued a statement urging healthcare professionals to give women better information on the risk of birth defects when Depakote and other valproate medicines are used during pregnancy. These medications are used to treat epilepsy and bipolar disorder.
Following a European review last year, which found that up to 40 percent of children born to women who take valproate during pregnancy may have developmental disorders and other birth defects, MHRA moved to strengthen product information. The agency is making informational booklets available to healthcare professionals and patients and the leaflet in the drug packing is being updated with stronger warnings about the risk of developmental disorders in children exposed to valproate during pregnancy. The review found that of 35,000 women prescribed valproate, 375 become pregnant per year while taking it.
Dr June Raine, director of MHRA’s vigilance and risk management of medicines division said the warnings on the risks of valproate in pregnancy have been strengthened “because 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.”
Women of childbearing age taking valproate should be given “effective contraception,” according to the MHRA statement and all women taking valproate should receive regular reviews of their treatment. Raine noted, though, that no one should stop taking valproate without first discussing this with the prescribing doctor.
The MHRA said the risk of birth defects due to valproate exposure in pregnancy has been included in the patient and prescriber information for several years. The European review better quantified and described the risk of developmental disorders, according to the MHRA statement.