Valproate is a treatment for epilepsy and bipolar disorder and is prescribed to thousands of women. Since its introduction in 1974, the product information for doctors has included a warning about the possible risk of birth defects. As the risks to unborn children have been increasingly understood, the warnings have been strengthened.
The risk of developmental disorders is up to 4 in 10 and the risk of birth defects is approximately 1 in 10.
MHRA (Medicines and Healthcare products Regulatory Agency) has worked with industry, healthcare professionals and patient groups on a toolkit to ensure female patients are better informed about the risks of taking valproate medicines during pregnancy.
Developed in consultation with stakeholders including healthcare professional and patient groups, the toolkit includes a credit card sized patient card to be issued by pharmacists, booklets for healthcare professionals and for patients together with a checklist of important questions and discussion points to be kept with the patient’s file.
The MHRA is asking GPs, pharmacists, neurologists, psychiatrists, and other relevant healthcare and mental health professionals to use the toolkit to help facilitate discussion of the risks with their patients.
Louise Cousins, campaigns manager at Epilepsy Action, said:
The new toolkit is an invaluable resource for women with epilepsy to better understand all aspects of pregnancy and the risks of taking valproate. By being fully informed, women can work together with health professionals to make the right choices for them and properly manage their care before, during and after pregnancy. This will help reduce the risk of malformations in babies born to women with epilepsy.
Suzanne Hudson, Chief Executive, Bipolar UK, said:
Valproate can be used to treat bipolar and other mental health conditions but it’s vital that women and girls are aware of the risks surrounding this medication. After working alongside the MHRA and other organisations, we welcome the launch of the new communications toolkit, which will provide women with the knowledge they need to make an informed decision with their doctor or psychiatrist.
You can read more about the MHRA Toolkit and its development here.