Patient survey: understanding the risks of sodium valproate

Are you a woman aged under 50? Are you currently taking sodium valproate (Epilim®, Depakote®, Episenta®) to treat migraine or have you in the past? Or have you ever discussed possibly taking sodium valproate with your doctor? If yes, then we are keen to hear from you.

We are working with the Medicines and Healthcare products Regulatory Agency (MHRA) to gather information on patient experiences with sodium valproate. The MHRA are an executive agency of the Department of Health and are responsible for regulating medicines in the UK.

Gathering data directly from patients is vital to help ensure that medicines are used safely and effectively and that patients are fully informed of the benefits and risks of the medicines they are taking. Sodium valproate is currently the subject of an extensive review across Europe and while it is not licenced in the UK for the treatment of migraine it is sometimes used for this so it is important that your experiences are heard.

Please be assured that your response is entirely anonymous, that individual responses will not be shared outside of the MHRA where they will be stored securely, and that the information you provide will be used only to inform the ongoing review of sodium valproate.

This short survey should only take a few minutes.

* 1. Have you ever taken sodium valproate to prevent migraine attacks?

* 2. Did you know that sodium valproate can, in some cases, negatively affect the development and/or physical health of children born to women taking this medication?

* 3. Have any of the following ever started a discussion with you about pregnancy and sodium valproate? (Select all that apply)

* 4. Which of these people have you seen in 2016/17, if any?

* 5. What risks to children born to mothers who have taken sodium valproate in pregnancy were discussed (select all that apply)?

* 6. Were you given information about any of the following issues (select all that apply)?

* 7. Did you fully understand the information given to you?

* 8. If you have planned a pregnancy or become pregnant while on sodium valproate did you?

* 9. Have you received any of the following items or advice from healthcare professionals in 2016/17? (Tick all that apply)

* 10. Q10: Have you seen any information on the use of sodium valproate in pregnancy on your medicine’s packaging?

* 11. When was your most recent discussion about pregnancy and sodium valproate?

* 12. What was the outcome of your most recent discussion about pregnancy and sodium valproate?

* 13. If you continue to take sodium valproate? (If answered “I was already prescribed sodium valproate and decided to continue taking it” to Q12)

Thank you very much for helping us with this survey.

Valproate is a treatment licensed for epilepsy and bipolar disorder and is prescribed to thousands of women. It is also used to treat migraine. Since its introduction in 1974, the product information for doctors has included a warning about the possible risk of birth defects in children born to women who were taking valproate when they were pregnant. As the risks to unborn children have been increasingly understood, the warnings have been strengthened.

MHRA has worked with industry, healthcare professionals, and patient groups on a toolkit designed to ensure female patients are better informed about the risks of taking valproate medicines during pregnancy. The information you have provided in responding to this survey will help us better understand how this toolkit is being used and where there is a need to take further measures to ensure that women taking valproate are fully aware of the potential risks.   

Further information on sodium valproate and the potential risks associated with taking it during pregnancy, along with the toolkit, can be found here:

https://www.gov.uk/government/publications/toolkit-on-the-risks-of-valproate-medicines-in-female-patients

In particular, a guide for women and girls who are taking sodium valproate can be found here:

http://www.medicines.org.uk/emc/RMM.421.pdf

If you want to talk about any of the issues raised in this survey, please talk to your GP or neurologist who will be best placed to discuss this with you and review your treatment if necessary. If you are taking valproate and think you might be pregnant or know you are pregnant, contact your doctor at once so that you can talk through your options. If you have experienced any side effects to this medicine you can report these to MHRA using the Yellow Card Scheme https://yellowcard.mhra.gov.uk/

Details on the ongoing review of the safety of sodium valproate can be found via the European Medicines Agency:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate_and_related_substances/human_referral_prac_000066.jsp&mid=WC0b01ac05805c516f

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