A credit card-sized patient information card that pharmacists can give to female patients to warn them about the risks of taking valproate while pregnant has been produced by the UK’s medicines safety watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA).
Two guides — one for healthcare professionals and another for female patients — have been included in an MHRA toolkit devoted to valproate, which is prescribed to treat seizures and bipolar disorder.
The move follows concerns that the risks of valproate have not been adequately explained to patients. These risks include birth defects in 1 in 10 babies if the drug is taken by women during pregnancy, while developmental disorders can occur in 4 in 10 births.
The MHRA hopes the toolkit will be used by health professionals to help trigger discussions with patients about the risks of the drug.
The patient card lists key facts about the risks associated with valproate and advises women what action to take if they are thinking of getting pregnant or are pregnant.
The patient guide covers the same ground in more detail and targets young girls and women of child bearing age. The health professionals’ guide outlines findings from research identifying the risks associated with valproate use and gives appropriate prescribing advice. A patient/prescriber check list is also included as part of the package.
The MHRA is in the process of bringing in new warnings about valproate on drug packaging.