We fight to improve the lives
of everyone affected by epilepsy

Warning message

This article was published in November 2013. The information may be out of date. Please check our epilepsy information or our site A-Z.

EMA reviews valproate in pregnancy

22 Nov 2013

The European Medicines Agency (EMA) is reviewing the use of valproate in pregnant women. Evidence from earlier this year suggests that its effects on an unborn child may be more serious than previously thought

It has been known for some time that valproate and related substances are not appropriate first-line medicines for pregnant women. (Some may have no choice than to take valproate during pregnancy if it is the only medicine that will successfully control seizures.) It is established that the drug can have some serious effects on the unborn child.

If exposed to valproate in the womb, the child may be born with a major congenital malformation (MCM). These may include things such as spina bifida or a cleft palate. There was also existing evidence suggesting that some delays in development may result from exposure to valproate in the womb.

Pregnant woman holding tabletsResearch published earlier this year further explored the effects of valproate and related substances on an unborn child. This research suggests that these effects may be more serious than was previously thought. For instance, valproate was linked with a higher risk of autistic spectrum disorder (ASD) in children exposed to it during pregnancy.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) recently requested a review of the drug. Information about the use of valproate during pregnancy is currently included in the medicine’s patient information. However, the MHRA insists that this information should be updated in the light of new research. It says the product information should highlight the potential risk of ASD.

The requested review has now started and is being conducted by the EMA. According to a news release, the EMA will review both the benefits and risks of valproate and related substances in pregnant women. The agency will release an opinion on the issue in due course.

Epilepsy Action stresses that no one should stop taking their medicine without medical supervision. If you have concerns about the side-effects of your medicine, email the epilepsy helpline or speak to your doctors.

There are no comments yet. Be the first to comment...

Question about your epilepsy?

Your question will be sent to our helpline advisors.

Have a comment about this page?

All comments are reviewed by a moderator before publishing. Comments will be edited or deleted if they are offensive, libellous, slanderous, abusive, commercial or irrelevant.

We ask for your email when you make a comment through this website. This means that we can let you know directly that we have replied to you. By making a comment through the website, you allow us to use the comment in our publicity without using your name. If we would like to use your name, we will email you to get your permission.

The content of this field is kept private and will not be shown publicly.
CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.
4 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.