Regulators will investigate cases in which a drug for epilepsy that can cause birth defects has been prescribed without proper warnings, in light of reports that pregnant women continue to give it.
Sodium valproate is a drug used to treat epilepsy and is also used in some people with bipolar disorder or migraines. However, it is associated with an increased risk of birth defects and developmental problems if taken by pregnant women.
Some unborn babies continue to be exposed to the drug: the latest figures reveal that 247 women were exposed to pregnancy between April 2018 and September 2021.
According to the Medicines and Health Products Regulatory Agency (MHRA), exposure to the drug during pregnancy has decreased in recent years, with a report from the Valproate Registry revealing that the number of pregnant women prescribed valproate sodium has fallen by 51%. between 2018-2018 financial year 19 and financial year 2020-21.
But an investigation by the Sunday Times also revealed reports of the drug being released without information leaflets or with covert warnings.
Dr Alison Cave, MHRA’s chief safety officer, said that every woman taking valproate sodium and their healthcare professional should sign an annual risk confirmation form.
She said: “The use of valproate during pregnancy carries significant risks of harm to the baby and should not be taken by people of childbearing potential unless they have a pregnancy prevention program that includes the use of effective contraception.
“We have also worked with the Ministry of Health and Welfare to seek public opinion in the United Kingdom on the requirements to ensure that medicines containing valproate sodium are always dispensed in the manufacturer’s original packaging so that it can be provided. important safety information for the risks of pregnancy with each prescription.
“If there are examples where this information is not provided, we will investigate.”
Matthew Walker, a professor of neurology at University College London and chairman of trustees at Epilepsy Research UK, said it was completely unacceptable for women with epilepsy not to be warned about the potential harmful effects of valproate sodium 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 mortality associated with epilepsy during pregnancy. Most people with epilepsy do not have access to doctors with experience in epilepsy so that they can be offered the best and most up-to-date advice.
Dr Rebecca Bromley, a research fellow and pediatric neuropsychologist at the University of Manchester, told the Guardian that babies exposed to sodium valproate are not only at higher risk of birth defects, but also cognitive and social difficulties.
She said: “The higher the dose of the drug, the greater the risk to the child. However, even at lower doses, we can see less intellectual and social disabilities. ” .
Bromley added that the response to the support of those affected has been too slow and that many families are struggling to get a diagnosis for their child or appropriate educational support.
Prof. Martin Marshall, president of the Royal College of General Practitioners, said that patients taking valproate sodium should not stop without seeking medical advice and should talk to their counselor or GP if they plan to have a baby.
“It is extremely important that all medicines have instructions on how to take them and that the warnings are clearly visible on or in the packaging, and we would encourage all patients to read them before taking them,” he said. “It is worrying that the Sunday Times investigation has identified cases of distribution of sodium valproate without visible relevant information.
This 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 then-Health Secretary Jeremy Hunt in 2018.
The survey estimated that 20,000 people in the UK were exposed to the drug as developing babies, revealing that many women reported not being warned about the risks by their doctor, confident the drug was safe or even told that if their baby has problems later, they can be “fixed”.
Following the report, the Valproate Safety Implementation Group was established. Last year, the NHS sent a letter to all women and girls aged 12 and over who had a current prescription for sodium valproate, noting the risks to unborn babies.
An NHS spokesman said the expert group’s goal was to help reduce the use of sodium valproate by women who could become 50% pregnant next year.
Hunt compares the use of sodium valproate among pregnant women to the thalidomide scandal, in which pregnant women are given a drug to fight morning sickness, which has been shown to cause serious birth defects.
“It is unbelievable that after so many warnings, this is still unresolved: it is a serious risk to patient safety and ministers must order immediate removal to prevent more avoidable damage,” he told the Sunday Times. .
A spokesman for the Ministry of Health and Social Welfare said: “Patient safety is a priority and we take all reports and inquiries on this issue very seriously.
“As stated in our reply, we have accepted most of the recommendations in Baroness Cumberlege’s report. We want to improve the future safety of medicines and medical devices – by ensuring that they are used in accordance with the latest evidence of best practice – and there are wider forms of compensation for those who need it.
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