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MHRA Urges Stronger Warnings for Women taking Valproate

Jan 23, 2015

The Medicines and Healthcare products Regulatory Agency (MHRA) is urging healthcare professionals to better inform women about the risks of taking valproate medicines, which are used to treat epilepsy and bipolar disorder. The product information was recently updated to include the risk of developmental disorders in children exposed to valproate during pregnancy.

According to MHRA, 375 out of 35,000 women prescribed valproate become pregnant each year.

Last year, a European review found that up to 40 percent of children who were exposed to valproate in the womb may have developmental problems. These deficits include delayed walking and talking, memory problems, difficulty with speech and language and lower intellectual ability. According to the review, previous research suggests an increased risk for childhood autism and autism spectrum disorders among children whose mothers took valproate during pregnancy. Additionally, there is an 11 percent increased risk of malformations at birth, such as cleft palate and neural tube defects, in these children.

"Doctors should ensure that their patients are adequately informed of the risks of taking valproate during pregnancy, and should regularly review the need for treatment in female patients who can have children. Doctors should also re-assess the balance of the benefits and risks of valproate medicines for any female patient who becomes or plans to become pregnant and for girls reaching puberty." the review stated.

The MHRA says that the warnings for valproate are being strengthened on the leaflet inside medicines packaging. Educational information booklets are also being produced for patients and healthcare professionals.

"The warnings on the risks of valproate in pregnancy have been further 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." said Dr June Raine, director of MHRA’s vigilance and risk management of medicines division. "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." No one should stop taking their prescribed medications without first speaking with their physician.

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