Medical negligence
I’m a clinical negligence solicitor; here is what you should know about sodium valproate
We spoke to Holly Cossutta, Senior Associate Solicitor at Slater and Gordon, to understand the risks of sodium valproate to pregnant women.
An estimated 20,000 babies have been affected by the harmful effects of sodium valproate. However, this number is argued to grow each year with many mothers still using the drug, unaware of its risk to their pregnancy.
The drug has been used to treat individuals with epilepsy since 1973, yet the concern for sodium valproate has only been recognised by regulatory authorities since 2018 following the publication of the Hughes Report.
What is Sodium Valproate?
Sodium valproate, also known as ‘valproate’ or ‘valproic acid’ is an anti-seizure drug, primarily used to treat epilepsy. It appears in different forms such as Epilim, Dyzantil, Convulex and Epival, and is also used to treat bi-polar disorder.
Sodium valproate is reported to control brain chemicals by sending signals to the nervous system, preventing seizures from occurring. It is regarded as one of the most effective epilepsy treatments and for some individuals, it is the only medication that helps control their seizures. In 2010, an estimated 14.3 million people in the UK were dispensed sodium valproate.
The conversation around its use has increased extensively after clear issues were being shown with babies having birth defects following drug usage in pregnant women.
What are the risks of sodium valproate to pregnant women?
It is estimated that 20,000 babies have been affected by sodium valproate.
Current statistics show that pregnant women who take sodium valproate, 10 per cent of babies are at risk of a birth defects such as spina bifida, deafness, facial malformations, and organ development. 40 per cent of babies can have problems with their learning and development, also known as ‘fetal anti-convulsant syndrome’ such as delayed walking, poor speech, or memory problems. Women are still being prescribed sodium valproate in particular circumstances under the Pregnancy Prevention Programme. Women using the drug must be aged 55 and over (outside childbearing age) and if sodium valproate is the only drug that works for their epilepsy.
Government recognition
After numerous years of confirmed cases and an EU-wide review, sodium valproate was officially recognised by the Medicines and Healthcare products Regulatory Agency (MHRA) as clear risk towards pregnant women.
In 2018, the MHRA introduced new measures to further protect girls and women from the effects of the drug including:
- Valproate medicines are not to be prescribed to women or girls of childbearing age, unless a Pregnancy Prevention Programme (PPP) is in place.
- Pregnancy risks are made clear with female patients when valproate medicines are dispensed.
- Clear warnings and potential risks are presented to the user with clear warning labels on medicine packs.
The Hughes Report: Redress victims harmed by sodium valproate
Last year, Dr Henrietta Hughes Patient Safety Commissioner published the Hughes Report, addressing options to redress individuals who had been harmed by sodium valproate. The report calls to action government compensation scheme to support families who have been impacted by the drug.
The report states that the recommended compensation package would start with an initial payment of £100,000.
Following the report by Dr Hughes, the government has acknowledged the report’s findings, but official government action is still yet to be taken.
Legal guidance
We spoke to Holly Cossutta, Senior Associate Solicitor from UK law firm, Slater and Gordon, to further understand the risks to pregnant women.
“If you have been prescribed sodium valproate before and during your pregnancy, and you believe your child was harmed by the drug - there may be an opportunity for you to make a claim. Our legal team are here to help you navigate these complex cases, where our in-depth expertise can help find the best solution for you and your child. Our medical negligence team will guide you every step of the way.”
As Holly adds:
“There are numerous women who have been let down by their doctor who failed to make the effects of sodium valproate clear to them.
“Sodium valproate is a common drug that over the years, mothers had relied on to help with their own medical challenges. However, it has caused harm to their loved ones, leaving many mothers to deal with the long-term effects these drugs have had.
“Mothers and their babies should have never been suffering in the first place, and they deserve the right to justice.”
For more information, email Holly.Cossutta@slatergordon.uk or call 0330 107 5078 to speak to one of our team members today.