New toolkit supports better understanding of the risks of valproate and pregnancy

  Important Information on the Risks of Valproate in Female Patients

Migraine Action help support MHRA in raising awareness around Valproate 

The Medicines and Healthcare products Regulatory Agency (MHRA) today welcomed the launch of a new toolkit to ensure female patients are better informed about the risks of taking valproate medicines during pregnancy.

Valproate (Epilim, Depakote and other generic brands) is a treatment for epilepsy and bipolar disorder and is prescribed to thousands of women. Some migraine patients are also prescribed valproate off license, as a preventative treatment. It is associated with a risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy.

The MHRA strengthened warnings on the risks of valproate in pregnancy last year, as understanding of the extent of these risks had increased. Up to 4 in 10 babies are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects, if valproate is taken during pregnancy. The new toolkit addresses concerns that the risks of valproate are not being adequately explained to female patients.

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. Warnings will appear on the medicine’s packaging later this year.

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.

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.

“It is important no-one should stop taking valproate without discussing it first with their doctor. If valproate is the only treatment option, women of childbearing age should be given effective contraception. Women taking valproate must have regular reviews of their treatment.” 


To find out more, visit MHRA >

 

Anyone with questions or concerns about the risks associated with valproate and pregnancy, should speak to their doctor, pharmacist or other healthcare professional. Anyone who has experienced any side effects to this medicine can report these to the MHRA using the Yellow Card Scheme. 

For patient information on valproate, download the patient booklet here > 

Valproate information for health care professionals can be found here > 


If you are taking valproate to help prevent migraine attacks, please speak to your doctor to discuss risks, contraception choices and alternative treatments. Additionally, contact Migraine Action for information on all preventative treatments. 

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