Ministers must order an “immediate fix” to prevent “avoidable harm” from a drug linked to health problems for children when taken by women during pregnancy, a former health secretary has said. Jeremy Hunt said anti-epilepsy drug sodium valproate - which has been linked to physical malformations, autism and developmental delay in many children when it is taken by their mothers while pregnant - is “a major risk to patient safety” as he called for it to be banned from being given to this group.
A review published in 2020 estimated 20,000 Britons had been affected after being exposed to the drug as developing babies. At that time, the review said “hundreds” of babies were still being born each year to mothers taking it who were unaware of the risks.
According to the latest figures, 222 pregnant women were exposed to sodium valproate in the period 2018/21, the Medicines and Healthcare products Regulatory Agency (MHRA) said. They said rates of exposure have been declining since the Pregnancy Prevention Programme was introduced, and rates in 2020/21 are “substantially lower”.
A spokesperson for NHS England said it has set up an expert group to help cut by 50% next year the use of valproate by women who can get pregnant. Mr Hunt told the Sunday Times : “It’s time the British state faced up to its responsibilities, just as we eventually did to victims of the thalidomide scandal.
“It beggars belief that after so many warnings this still hasn’t been sorted. This is a major risk to patient safety and ministers must order an immediate fix to prevent any more avoidable harm.”
Dr Alison Cave, MHRA chief safety officer, said valproate use in pregnancy carries “significant risks of harm to the baby”. She added it “should not be taken by any individual of child-bearing potential unless they have a pregnancy prevention programme in place, which includes use of effective contraception”.
Each year, every woman on the drug needs to sign an annual risk acknowledgement form together with their healthcare professional, as her circumstances regarding the risk of pregnancy might change, Dr Cave added. She said work is continuing on use of the drug in people “where there are no other viable options available”.
Mr Hunt launched a review in 2018 into how the health service responded to concerns over sodium valproate. That review also looked at pelvic mesh - which has been linked to crippling, life-changing complications including chronic pain, infections and loss of sex life - and hormone pregnancy tests such as Primodos, which are thought to be associated with birth defects and miscarriages.
The review, chaired by Baroness Cumberlege, made a series of recommendations. These included the appointment of an independent patient safety commissioner who sits outside the healthcare system; a call for the Government to issue an immediate “fulsome apology” on behalf of the healthcare system to the families affected; reform at the medicine and medical devices regulatory body, and a register for all “financial and non-pecuniary interests for all doctors”.
In response to the Sunday Times story, a spokesperson for the Department of Health (DH) said: “Patient safety is a priority and we take all reports and inquiries on this matter extremely seriously. As set out in our response, we have accepted the majority of the recommendations in Baroness Cumberlege’s report."
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