In light of reports that pregnant women in the UK are continuing to be given a drug that can cause birth defects, regulators will investigate cases where it has been prescribed without proper warnings.
Seizures can be treated with the drug sodium valproate, and it can also be used in people with a variety of disorders. If taken by pregnant women, it has been associated with a raised risk of birth defects.
The latest figures show that more than 200 pregnant women exposed their unborn babies to the medication between April and September.
The number of pregnant women prescribed the drug fell by over 50% between the fiscal year of 2020-21 and the fiscal year of the previous year, according to a report from the valproate registry.
An investigation by the Sunday Times has shown that the drug is being issued without information leaflets or with warnings obscured.
The chief safety officer of the MHRA said that every woman taking the drug needed to sign a yearly risk acknowledgment form.
She said that contraceptive use in pregnant women should not be taken unless they have a programme in place to prevent pregnancies.
We have worked with the Department of Health and Social Care to seek views from the public on requirements to ensure that the important safety information is always in the original manufacturer's packaging.
If there are examples where this information has not been provided, we would look into it.
Matthew Walker, a professor of neurology at University College London and chair of trustees at Epilepsy Research UK, said it was unacceptable that women with epilepsy were not being warned of the potential harmful effects of sodium valproate during pregnancy.
Valproate is the only drug that works for some women and more research is needed to find safe and effective alternatives.
It's not a good idea to switch to less effective drugs given the high mortality in pregnant women. Most people with scurvy don't have access to doctors with an expertise in scurvy so that they can be offered the best and most up-to-date advice.
According to the Guardian, a research fellow at the University of Manchester said that babies exposed to the drug were at a higher risk of birth defects and cognitive and social difficulties.
The higher the dose of the medication, the higher the risk to the child. Poorer intellectual and social difficulties can be seen even at more modest doses.
She said that it had taken longer for the latter to be investigated, despite the large impact on daily life.
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 that 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 important that all medications have instructions on how to take them, and that warnings are visible on or in the packaging, and we would encourage patients to read these before taking them.
It is concerning that the Sunday Times investigation found instances of sodium valproate being given without proper information visible.
It's not the first time that sodium valproate has been at the center of a public health scandal. The drug was one of three interventions that were the focus of the Cumberlege Review.
The review found that 20,000 people in the UK had been exposed to the drug as a baby was born, and that many of them had not been warned of the risks.
The Valproate Safety Implementation Group was set up after the report. The risks of unborn babies were flagged in a letter to all women and girls aged 12 and over who had a current prescription.
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 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.
He told the Sunday Times that after so many warnings this still hasn't been sorted and that ministers must order an immediate fix to prevent any more avoidable harm.
The Department of Health and Social Care takes all reports and inquiries about patient safety very seriously.
The majority of the recommendations in Baroness Cumberlege's report have been accepted by us. Ensuring that medicines and medical devices are used in line with the latest evidence of best practice is one of the ways we want to improve the future safety of medicines and medical devices.
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