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 an increased risk of genetic abnormalities and developmental problems if taken by pregnant women. Some unborn babies continue to be exposed to the drug: the latest data reveal that 247 women were exposed to pregnancies between April 2018 and September 2021. According to the Drugs and Health Products Regulatory Authority (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 on prescription sodium valproate has decreased. by 51% between 2018- financial year 19 and the financial year 2020-21. However, an investigation by the Sunday Times also revealed reports of the drug being issued without brochures or with vague warnings. Dr. Allison Cave, head of security at MHRA, said every woman taking sodium valproate, and their healthcare professional, had to sign an annual risk identification form. He said: “The use of valproate in pregnancy carries a significant risk of harm to the baby and should not be taken by anyone of childbearing potential unless they have established a contraception program that includes the use of effective contraception. “We have also worked with the Ministry of Health and Social Welfare to seek feedback from the UK public on requirements to ensure that sodium valproate-containing medicines are always delivered in the original packaging of the manufacturer, so that important safety information can be provided. with the risks during pregnancy with every prescription given. “If there are examples where this information has not been provided, we would investigate.” Matthew Walker, a professor of neurology at University College London and chair of the Commissioner at Epilepsy Research UK, said it was completely unacceptable for women with epilepsy not to be 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 find safe and effective alternatives,” she said. “Switching to less effective drugs is often not a sensible alternative, given the high mortality associated with epilepsy during pregnancy. “Most people with epilepsy do not have access to doctors who specialize in epilepsy, so they can be offered the best and most up-to-date advice.” Dr Rebecca Bromley, a researcher and child neuropsychologist at the University of Manchester, told the Guardian that babies exposed to sodium valproate were not only at higher risk for genetic disorders but also for cognitive and social difficulties. He said: “The higher the dose of the drug, the greater the risk to the child. However, even in more moderate doses we can see poorer mental and social difficulties. ” It took more time to explore the latter, he added, despite the major impact on daily life – including challenges with logic, mindfulness learning and language skills. Bromley added that the response to support for those affected was too late and that many families were finding it difficult to get a diagnosis or appropriate educational support for their child. Professor Martin Marshall, president of the Royal College of GPs, said that patients taking sodium valproate should not stop without seeking medical advice and should talk to their counselor or doctor if they are planning to have a baby. “It is vital that all medicines have instructions on how to take them and that the warnings are clearly visible on or on the package, and we will encourage all patients to read them before taking them,” he said. “It is worrying that the Sunday Times investigation found cases of sodium valproate administration without the appropriate information being visible.” This is not the first time that sodium valproate has been at the forefront of a public health scandal. The drug was one of three interventions at the heart of the Cumberlege inspection launched by then-Health Minister 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 said they had not been warned of the dangers by their doctor, were convinced the drug was safe or even told they should their baby. then they have problems that could be “corrected”. Following the report, the Valproate Safety Implementation Team 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, pointing out the dangers of unborn babies. An NHS spokesman said the goal of the panel of experts was to help reduce the use of sodium valproate by women who could become pregnant by 50% next year. Hunt compared the use of sodium valproate among pregnant women with the thalidomide scandal, in which pregnant women received a drug to treat morning sickness that was found to cause serious genetic abnormalities. “It’s a belief that after so many warnings this has not yet been resolved: this is a significant risk to patient safety and ministers must order an immediate solution to avoid any other harm that could have been avoided,” he told 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 extremely 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 – by ensuring that they are used according to the latest evidence of best practice – and there are broader forms of remedies available to those who need them.”
