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Written on 8th April 2022 by Susan Brown

Figures published by NHS Digital, and reported by The Pharmaceutical Journal, show that in a 12 month period between October 2020 and September 2021 nearly 50 women in England were prescribed sodium valproate during pregnancy

The figures were taken from administrative data kept by NHS Digital which is working in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA) to develop registries to monitor and understand the use, benefits, and risks of medicines such as sodium valproate when they are taken by women in pregnancy.

The anti-epileptic drug, sodium valproate, is known to cause physical and neurological disability in up to 40% of babies born to women who take it in pregnancy. 

What is sodium valproate?

Sodium valproate is a very effective anti-convulsant drug, which is used to treat epilepsy and bipolar disorder. It is often known by its brand names, such as Epilim, Epival, Episenta and Depakote. Despite valproate’s effectiveness in reducing fits (seizures or convulsions) in people who suffer from epilepsy, it carries a high risk of physical and neurodevelopmental injury, sometimes called ‘birth defects’, in babies whose mothers take the drug whilst they are pregnant. 

In 2018, after decades of developing awareness around valproate’s harmful effects on unborn babies and failed attempts to stop doctors prescribing sodium valproate to girls and women who could become pregnant,  the prescription of valproate for girls or women of childbearing age was banned, unless no alternative treatment could control their epilepsy.  Where no other anti-convulsant drug can control a girl’s or woman’s epilepsy, valproate can be prescribed but only under strict guidelines and licensing regulations. The guidelines mandate strict, documented procedures to ensure that the women is fully informed about the high risk of serious injury to unborn babies from valproate in pregnancy, is regularly reviewed, and uses effective contraception under a pregnancy prevention programme (PPP).

Following the shocking findings set out in the IMMDS Review report, ‘First Do No Harm’,  in July 2020, NHS England set a target to halve the number of women of childbearing age who are prescribed valproate by 2023. The use of registries and data collection is intended to support the MHRA in monitoring whether the valproate pregnancy prevention plan (PPP) is working, and help the wider healthcare system understand the effect of valproate during pregnancy to improve patient safety.

How many women in England are still being prescribed valproate in pregnancy?

NHS Digital’s reported data suggests that 949 women in England who were on the valproate register had a pregnancy since April 2018. Of those, 247 were prescribed valproate during their pregnancy.

46 of these women were prescribed sodium valproate during pregnancy in the most recent 12-month reporting period from October 2020 to September 2021.  This is compared with 65 women being prescribed valproate in pregnancy in the previous 12 months.

In September 2021, just over 40% of all women who were prescribed the drug were aged between 16 and 44 years. Whilst the number of women receiving valproate in this age category had reduced, the childbearing age category represented the same proportion of valproate prescriptions as the previous year.  

In September 2021, 206 women/girls were classed as new starters for valproate treatment on the register compared with 195 in September 2020.  This meant that they had been prescribed sodium valproate having not had it (or not had it recorded) before. A total of 20,192 women or girls were prescribed valproate in September 2021.

Compensation for babies and children injured by negligent prescription of sodium valproate

Epilepsy is a life-threatening and often distressing condition which requires specialist medical care, particularly around the time that a woman is planning or experiencing pregnancy. Sodium valproate is now known, unequivocally, to cause serious, lifelong harm to up to 40% of babies whose mothers take valproate during pregnancy. This harm includes developmental problems and learning difficulties, sometimes known as fetal anti-convulsant syndrome (FACS), and physical disability from spina bifida, malformations of limbs, face and skull, and injury to internal organs.

The government rejected the Cumberlege Review’s strong recommendation that those injured by valproate should be compensated by a government redress agency. This means that the only redress that injured victims of valproate prescribing negligence have is to make a medical negligence claim for compensation.

If your GP or hospital doctor failed to provide you with proper information and warn you of the risks, review your care and follow the safety guidelines when prescribing valproate before or during your pregnancy, your injured child may be entitled to substantial compensation.

Boyes Turner’s clinical negligence team are currently helping families with claims for valproate compensation.

If you or your child has been injured as a result of medical negligence, you can talk to one of our solicitors, free and confidentially, to find out more about making a claim by contacting us here.