The drug for epilepsy sodium valproate has been given to women in the UK for years without proper warnings, the Sunday Times reported. Jeremy Hunt, the former Minister of Health, called for an “immediate solution” to avoid the “damage” allegedly caused by the drug. A review published in 2020 estimates that 20,000 Britons were affected after exposure to the drug as developing babies. At the time, the review reported that “hundreds” of babies were still being born each year by mothers who took it, who were unaware of the risks. According to the latest data, 222 pregnant women were exposed to sodium valproate in the period 2020-2021, according to the Regulatory Agency for Drugs and Health Products (MHRA). They said exposure rates have been falling since the Prevention of Pregnancy Program was introduced and rates in 2020-2021 are “substantially lower”. Mr Hunt said sodium valproate was a “major risk to patient safety” as he called for a ban on its use in pregnant women. An NHS England spokeswoman said she had set up a team of experts to help reduce the use of valproate by 50 percent of pregnant women next year. Janet Stockley-Pollard, one of the mothers who claims that the drug sodium valproate, also known as Epilim, caused a number of genetic abnormalities at a press conference in London in 2011 (PA) Mr Hunt told the Sunday Times: “It’s time for the British government to face its responsibilities. Just like we did to the victims of the thalidomide scandal. “It takes conviction 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 harm that could be avoided.” He said it was time for the NHS to “stop dragging its feet on it”, saying “it is not right to risk disability for so many babies when the effects of the drug are so well known”. Dr Alison Cave, head of security at MHRA, said the use of valproate in pregnancy posed a “significant risk of harm to the baby” and “should not be taken by anyone with childbearing potential unless they have implemented a contraception program that includes the use of effective contraception “. Each year, every woman taking the drug must sign an annual risk identification form with her healthcare professional, as her circumstances regarding the risk of pregnancy may change, Dr. Cave added. He said work was continuing on the use of the drug in people “where there are no other viable options available”. He added: “Our work on the safety of sodium valproate continues and we will continue to review, adapt and implement regulatory measures where necessary to allow the continued safe use of this drug in persons who may become pregnant where there is no other viable options available. “ Mr. Hunt launched a review in 2018 on how the health service responded to sodium valproate concerns. This review also looked at the pelvic floor – which has been linked to life-changing complications such as chronic pain, infections and loss of sex life – and hormonal pregnancy tests such as Primodos, believed to be linked to genetic abnormalities and miscarriages. Back row, from left to right: Susan Cole, Janet Williams, Samantha Scott. Front row, from left to right: Janet Stockley-Pollard and Emma Friedmann, all mothers who claim that sodium valproate caused a number of genetic abnormalities (PA) The critique, chaired by Baroness Cumberlege, made a number of recommendations. These included the appointment of an independent commissioner for patient safety outside the healthcare system. a call to the government to issue an immediate “full apology” from the health care system to the affected families; reform of the regulatory body for medicines and medical devices; The Sunday Times reported that a package of the drug was given without a leaflet on patient safety information inside. The MHRA said it would investigate any examples where important safety information about the risks during pregnancy has not been provided. Responding to the Sunday Times story, a Health Department (DH) spokesman said: “Patient safety is a priority and we take all reports and inquiries 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 – 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.” An NHS spokeswoman for England said: “The NHS has set up a team of experts to help reduce the use of valproate by women who may become pregnant by 50 per cent next year. “Last year the NHS wrote to all women and girls aged 12-55 in England about medication to remind them of the dangers of the drug when they are pregnant and has worked with partners on a number of initiatives to support it. reducing the risks of valproate “.
