David Gazzard is a senior clinical negligence lawyer who heads the Clinical Negligence Team at BLB Solicitors. In recent years, David has developed a national reputation for working with families whose unborn babies have been exposed to sodium valproate.
To speak to David informally and in complete confidence, please call 01225 866541, or email him: firstname.lastname@example.org
Sodium valproate is again in the news. While any publicity concerning this controversial drug is welcome, the story behind these latest headlines is simply that little has changed in the four years since the last wave of publicity. The drug continues to be prescribed to pregnant women in the UK, and safety information and warnings are often woeful or even non-existent.
Sodium valproate pregnancy
Sold under the brand names Epilim, Dyzantil, Episenta, and Epival, sodium valproate is a drug long used to treat epilepsy, bipolar disorder, and sometimes migraine. However, if taken during pregnancy, there is a 40% chance of the child being born with developmental problems, including autism, low IQ, and learning disabilities. In addition, there is a 10% chance of the drug causing physical abnormalities.
In February 2016, the European Medicines Agency (EMA) recommended overhauling the information and warnings provided to patients concerning these substantial risks. Yet, a year later, the British Medical Journal reported the results of a survey suggesting more than two-thirds of women taking the drug “had not received new safety warnings about the dangers of taking it during pregnancy”. The survey also found that one in six women taking sodium valproate was entirely unaware of the risks, and 21% had never had the risks raised with them by a medical professional.
Fast forward to this year and on 17th April, under the headline, “A scandal worse than thalidomide”, The Sunday Times reported that doctors are still failing to provide women with adequate warnings of these huge risks.
According to figures published by NHS Digital, since April 2018 in England, 949 women on the sodium valproate register have had a pregnancy, of whom 247 continued to be prescribed the drug during their pregnancy. While the figures do demonstrate a year-on-year reduction in the number of prescriptions issued during pregnancy, we are still faced with the reality that each month, around six babies are born in the UK who have been exposed to the drug.
Of particular concern, The Sunday Times investigation found that in some instances, women were dispensed their sodium valproate prescription in plain packaging with no information leaflet or with stickers placed over the warnings.
Sadly, these reports come as no surprise to me. For the last 6 years, I have been working with those most seriously affected by sodium valproate exposure, and it’s been an uphill struggle to find anyone in the medical profession prepared to concede the profession’s failings. I’ve met with mothers who, before becoming pregnant, have actively sought advice from their GPs or treating neurologists and received reassurance and advised to continue taking the drug during their pregnancy.
Although there is some debate about exactly how long the medical profession has been aware of these risks, I have seen expert evidence suggesting it has been widely known since at least 2005/2006.
In 2020, after a two-year review led by Baroness Cumberlege, the Independent Medicines and Medical Devices Safety Review was published. The report was highly critical of the lack of support provided to families affected by sodium valproate and recommended the government provide financial help. But so far, they have refused to do so, despite two early day motions tabled in the House of Commons calling for the immediate implementation of the Review’s recommendations.
Currently, litigation remains the only avenue open to families in desperate need of financial assistance. However, these cases are highly complex and even where the evidence is strong, there is no short-term solution for those needing help now.