Regulators will investigate cases where an epilepsy drug that can cause birth defects has been prescribed without proper warnings, in light of reports that pregnant women in the UK are continuing to be given it.
Sodium valproate is a drug used to treat epilepsy, and is also used in some people with bipolar disorder or migraines. However, it has been associated with a raised risk of birth defects and developmental problems if taken by pregnant women.
Some unborn babies continue to be exposed to the medication: the latest figures reveal 247 women had exposed pregnancies between April 2018 and September 2021.
According to the Medicines and Healthcare products Regulatory Agency (MHRA), exposure to the drug during pregnancy has declined in recent years, with a report from the valproate registry revealing that the number of pregnant women prescribed sodium valproate fell by 51% between the 2018-19 financial year and the 2020-21 financial year.
But an investigation by the Sunday Times has also revealed reports of the drug being issued without information leaflets, or with warnings obscured.
Dr Alison Cave, the MHRA’s chief safety officer, said every woman taking sodium valproate, and their healthcare professional, needed to sign a yearly risk acknowledgment form.
She said: “Valproate use in pregnancy carries significant risks of harm to the baby and it should not be taken by any individual of child-bearing potential unless they have a pregnancy prevention programme in place, which includes use of effective contraception.
“We have also worked with the Department of Health and Social Care to seek views from the UK public on requirements to ensure medicines that contain sodium valproate are always dispensed in the original manufacturer’s packaging, so that the important safety information on risks in pregnancy is provided with every dispensed prescription.
“If there are examples where this information has not been provided, we would investigate this.”
Matthew Walker, a professor of neurology at University College London and chair of trustees at Epilepsy Research UK, said it was completely unacceptable that women with epilepsy were not being warned of the potential harmful effects of sodium valproate during pregnancy.
“Unfortunately, for some women, valproate is the only drug that successfully controls their epilepsy and more research is needed to identify safe and effective alternatives,” he said.
“Switching to less-effective drugs is often not a reasonable alternative given the high epilepsy-related mortality in pregnancy. Most people with epilepsy do not have access to doctors with an expertise in epilepsy so that they can be offered the best and most up-to-date advice.”
Dr Rebecca Bromley, a research fellow and paediatric neuropsychologist at the University of Manchester, told the Guardian that babies exposed to sodium valproate were not only at a higher risk of birth defects but also cognitive and social difficulties.
She said: “The higher the dose of the medication, the higher the risk to the child. However, even at more modest doses we can see poorer intellectual and social difficulties.”
It had taken longer for the latter to be investigated, she added, despite the large impact on daily life – including challenges with reasoning, attention learning and language skills.
Bromley added that the response to support affected individuals had moved too slowly, and that many families struggled to obtain a diagnosis for their child or appropriate educational support.
Prof Martin Marshall, chair of the Royal College of GPs, said patients taking sodium valproate should not stop without seeking medical advice, and should talk to their consultant or GP if they were planning to have a baby.
“It is vital that all medications have instructions on how to take them, and that warnings are clearly visible on or in the packaging, and we would encourage all patients to read these before taking them,” he said.
“It is concerning that the Sunday Times investigation found instances of sodium valproate being dispensed without appropriate information visible.”
It is not the first time sodium valproate has been at the heart of a public health scandal. The drug was one of three interventions that were the focus of the Cumberlege Review, launched by the then health secretary, Jeremy Hunt, in 2018.
The review estimated 20,000 people in the UK had been exposed to the drug as developing babies, revealing that many women reported they had not been warned of the risks by their doctor, were reassured the drug was safe, or were even told that should their baby subsequently have problems these could be “fixed”.
After the report, the Valproate Safety Implementation Group was set up. Last year, the NHS sent a letter to all women and girls aged 12 and over who had a current prescription for sodium valproate, flagging the risks posed to unborn babies.
An NHS spokesperson said the aim of the expert group was to help reduce the use of sodium valproate by women who could get pregnant by 50% next year.
Hunt has compared the use of sodium valproate among pregnant women to the thalidomide scandal, in which pregnant women were given a drug to counter morning sickness that turned out to cause serious birth defects.
“It beggars belief that after so many warnings this still hasn’t been sorted: this is a major risk to patient safety and ministers must order an immediate fix to prevent any more avoidable harm,” he told the Sunday Times.
A Department of Health and Social Care spokesperson said: “Patient safety is a priority and we take all reports and inquiries on this matter extremely seriously.
“As set out in our response, we have accepted the majority of the recommendations in Baroness Cumberlege’s report. We want to improve the future safety of medicines and medical devices – ensuring they are used in line with the latest evidence of best practice – and there are wider forms of redress available for those who need it.”
