Healthcare professionals are today being urged by the Medicines and Healthcare products Regulatory Agency (MHRA) to give women better information on the risks associated with valproate medicines, (used to treat epilepsy and bipolar disorder) following the strengthening of product information.
Information booklets for healthcare professionals and patients are being made available as educational tools. The leaflet inside medicines packaging is also being updated with stronger warnings about the risk of developmental disorders in children exposed to valproate during pregnancy.
This follows the outcome of a European review last year which found that up to 40% of children born to women who take valproate during pregnancy may have developmental disorders.
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 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.
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.
However, it is important that no-one should stop taking valproate without discussing it first with their doctor.
The risk of birth defects in children whose mothers take valproate during pregnancy has been included in the information for patients and prescribers for several years. Of 35,000 women prescribed valproate, 375 become pregnant per year whilst taking it. The main outcome of the European review has been to better quantify and describe the risk of developmental disorders.
If you have experienced any side effects to this medicine you can report these to us using the Yellow Card Scheme
- See the European Medicines Agency Review
- NICE is assessing the impact of the advice on their 2 guidelines for epilepsy and bipolar to consider whether updates will be necessary. Healthcare professionals are advised to use the current guidelines in conjunction with the latest MHRA advice.
MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lays robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health. See the MHRA website for more information.
- See Central Alerting System