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Home » Latest News » Fetal Valproate Spectrum Disorder- an avoidable problem?

Fetal Valproate Spectrum Disorder- an avoidable problem?

Fetal Valproate Spectrum Disorder- an avoidable problem?

Over Easter 2022 the Times newspaper reported that a drug used to treat epilepsy may have damaged up to 20,000 babies in the UK , when it was prescribed mothers whilst she was pregnant.

There are a number of drugs used to treat epilepsy. They are usually safe when used appropriately, although each have side-effects.

Sodium Valproate is known to cause developmental problems, including spina bifida, for some unborn children if it is taken by their mother during pregnancy. The medication is more commonly known as Epival, Depakote, Episenta or, Epilim.

Sodium Valproate was first licensed in the mid 1970s. In the 1980s reports in scientific journals began to appear suggesting this drug may be associated with an increased risk of developmental problems for some babies.

It was not until 2018 when the European Medicines Agency recommended that the use of Sodium Valproate should be restricted for pregnant women and used only where other alternative epilepsy drugs  wouldn’t be expected to work.

In the UK the Medicines and Healthcare products Regulatory Agency (MHRA) said, in 2018, that “Valproate medicines must not be used in women of childbearing potential unless the Pregnancy Prevention Programme is in place.”

In 2019 a group of experts looked at a lot of research and said “exposure to [Sodium Valporate] can have variable effects, ranging from a characteristic pattern of major malformations and significant intellectual disability to the other end of the continuum, characterised by facial dysmorphism which is often difficult to discern and a more moderate effect on neurodevelopment and general health. It has become clear that some individuals with [fetal valproate spectrum disorder]  have complex needs requiring multidisciplinary care but information regarding management is currently lacking in the medical literature.”

The Epilepsy Society provide guidance if you are taking this drug and either wish to become pregnant or are pregnant.

A review published in 2020 by Baroness Cumberlege states “In the UK [there was] the launch of a valproate ‘Toolkit’ in 2016, which provided information for patients and healthcare professionals, and the Pregnancy Prevention Programme (PPP) in 2018. Currently all girls and women of childbearing potential should only be treated with valproate if the conditions of the PPP are met:
• They should have received counselling about the risks of valproate treatment and the need for effective contraception and have signed a Risk Acknowledgement Form
• They are on highly effective contraception
• They are reviewed by their specialist at least annually”

The UK government current advice is “Valproate must not be used in any woman or girl able to have children unless there is a pregnancy prevention programme (PPP) in place.”

The recent series of articles in newspapers, and the available scientific knowledge, leads to the possibility that some mothers have not been, and are not, properly informed of the risks and benefits of the use of this drug during pregnancy, and therefore may have been given the drug without providing informed consent to the use of Sodium Valproate. All expectant mothers ought to have been provided with a relevant patient information leaflet, as well as an explanation.

If this then leads to damage to their baby it could lead to a claim for compensation for clinical negligence.

If you took sodium valproate during a pregnancy and that child is under 5 years of age and has symptoms of foetal valproate spectrum disorder  (including neural tube defects (like spina bifida), distinctive facial features, congenital heart defects and other musculoskeletal abnormalities)  then there may be a claim for medical negligence compensation.

Please contact us https://www.bridgemcfarland.co.uk/contact for an initial, no obligation discussion.

 

https://www.thetimes.co.uk/article/20-000-babies-damaged-and-still-the-scandal-continues-q7rjdskfx

https://metro.co.uk/2022/04/17/drug-that-harmed-20000-babies-still-being-given-to-pregnant-women-16481906/

https://bnf.nice.org.uk/drug/sodium-valproate.html#pregnancy

https://www.gov.uk/drug-safety-update/valproate-pregnancy-prevention-programme-actions-required-now-from-gps-specialists-and-dispensers

https://ojrd.biomedcentral.com/articles/10.1186/s13023-019-1064-y

https://epilepsysociety.org.uk/about-epilepsy/sodium-valproate

https://immdsreview.org.uk/downloads/IMMDSReview_Web.pdf

https://www.gov.uk/guidance/valproate-use-by-women-and-girls