MHRA to investigate cases of dangerous epilepsy drugs given to pregnant women | Health

Regulators will investigate cases where an epilepsy drug that can cause birth defects has been prescribed without proper warning, in light of reports that pregnant women in the UK continue to receive it.

Sodium valproate is a drug used to treat epilepsy and is also used in some people with bipolar disorder or migraine headaches. However, it has been linked to 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 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 given sodium valproate was prescribed fell 51% between 2018 and 2018. 19 fiscal year and 2020-21 fiscal year.

But a Sunday Times investigation also revealed reports that the drug was distributed without information leaflets or with obscured warnings.

MHRA safety officer Dr Alison Cave said every woman taking sodium valproate and her healthcare professional must sign an annual risk acknowledgment form.

She said: ‘The use of valproate during pregnancy carries significant risks of harm to the baby and it should not be taken by anyone of childbearing potential unless they have a prevention program in place. of pregnancy, which includes the use of effective contraception.

“We have also worked with the Department of Health and Social Care to seek the UK public’s views on requirements to ensure medicines containing sodium valproate are always distributed in the original manufacturer’s packaging, so that important safety information about the risks during pregnancy is provided. with each prescription issued.

“If there are instances where this information has not been provided, we will investigate that.”

Matthew Walker, professor of neurology at University College London and chairman of the board of Epilepsy Research UK, said it was completely unacceptable that women with epilepsy were not warned about 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 medications is often not a reasonable alternative given the high epilepsy-related mortality during pregnancy. Most people with epilepsy do not have access to doctors who specialize in epilepsy so that we can offer them the best and most up-to-date advice.

Dr Rebecca Bromley, a researcher and pediatric neuropsychologist at the University of Manchester, told the Guardian that babies exposed to sodium valproate were not only at higher risk of birth defects, but also of cognitive and social difficulties.

She said: ‘The higher the dose of medicine, the higher the risk to the child. However, even at more modest doses, we can see lower intellectual and social difficulties.

It took longer for the latter to be studied, she added, despite the significant impact on daily life – including challenges in reasoning, attention learning and language skills.

Bromley added that the response to support those affected had moved too slowly and many families were struggling to get a diagnosis for their child or proper educational support.

Professor Martin Marshall, president of the Royal College of GPs, said patients taking sodium valproate should not stop without consulting a doctor and should speak to their consultant or GP if they are considering having a baby.

“It is essential that all medicines have instructions on how to take them and that warnings are clearly visible on or in the packaging, and we encourage all patients to read these before taking them,” he said. he declares.

“It is concerning that the Sunday Times investigation revealed cases of sodium valproate being distributed without the appropriate information being visible.”

This is not the first time that sodium valproate has been at the heart of a public health scandal. The drug was one of three interventions at the center of the Cumberlege review, launched by then-Health Secretary Jeremy Hunt in 2018.

The review estimated that 20,000 people in the UK had been exposed to the drug as developing babies, revealing that many women said they had not been warned of the risks by their doctor, that they had been reassured that the medicine was safe or even told that their baby should have problems later on, these could be ‘fixed’.

After the report, the Valproate Safety Implementation Group was created. Last year the NHS sent a letter to all women and girls aged 12 and over who had a current prescription for sodium valproate, warning of the risks posed to unborn babies.

An NHS spokesperson said the expert group’s aim was to help reduce the use of sodium valproate by women at risk of becoming pregnant by 50% within the next year.

Hunt compared the use of sodium valproate in pregnant women to the thalidomide scandal, in which pregnant women were given a drug to counter morning sickness that was found to cause serious birth defects.

“It beggars belief that after so many warnings it has still not been addressed: this is a major risk to patient safety and ministers must order an immediate remedy to avoid any further preventable 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 about it very seriously.

“As stated 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 accordance with the latest evidence of best practice – and there are broader forms of redress available to those who need them.

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