The Medicines and Healthcare products Regulatory Agency (MHRA) has produced a new toolkit to ensure that female patients are better informed about the risks of taking valproate medicines during pregnancy.
Prescribed to thousands of women, valproate (for example, Epilim, Depakote and other generic brands) is a treatment for epilepsy and bipolar disorder. However, the drug is associated with an increased risk of birth defects and developmental disorders if taken during pregnancy.
Developed with healthcare professionals and patient groups, the toolkit includes a patient card to be issued by pharmacists, information booklets for healthcare professionals and patients, together with a checklist of important questions and discussion points to be kept with the patient’s file. Warnings will appear on valproate packaging later this year.
Dr Sarah Branch, deputy director of MHRA’s Vigilance and Risk Management of Medicines Division, said: “The warnings on the risks of valproate in pregnancy were strengthened last year. We want to ensure that women and girls have the latest information about the risks of developmental disorders and birth defects in children exposed to valproate during pregnancy. This new toolkit supports healthcare professionals to give that advice to their patients.”
Welcoming the toolkit, Royal Pharmaceutical Society (RPS) English Pharmacy Board chair Sandra Gidley added: “We will be urging pharmacists to use the toolkit as a way of facilitating conversations they have with patients about the risks of taking valproate medicines during pregnancy.”