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Health & Fitness: Drug that harmed 20,000 babies 'still being given to pregnant women'

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The epilepsy medication has been known to cause problems in babies for nearly 50 years (Picture: Getty) © Provided by Metro The epilepsy medication has been known to cause problems in babies for nearly 50 years (Picture: Getty)

A drug which has harmed at least an estimated 20,000 Brits is still being prescribed to pregnant women without appropriate warnings, a former health secretary says.

The anti-epilepsy medication sodium valproate – which has been linked to physical malformations, autism and developmental delay in many children when it is taken by their mothers – is ‘a major risk to patient safety’, according to Jeremy Hunt.

He urged ministers to find an ‘immediate fix’ to prevent ‘avoidable harm’.

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Doctors are said to have known in 1973 that the epilepsy drug posed a risk to unborn children.

Yet almost 50 years later, a review published in 2020 estimated that 20,000 young Britons had been affected after being exposed to it as developing babies.

At that time, the findings suggested ‘hundreds’ of babies were still being born each year to mothers taking sodium valproate without being aware of the risks.

Newer figures suggest 222 pregnant women were exposed to the drug from 2018 to 21, the Medicines and Healthcare products Regulatory Agency (MHRA) said.

Valproate sodium has been known to cause damage to unborn babies for decades (Picture: Getty Images) © Provided by Metro Valproate sodium has been known to cause damage to unborn babies for decades (Picture: Getty Images)

It said exposure rates have been declining since the Pregnancy Prevention Programme was introduced, and rates in 2020/21 are ‘substantially lower’.

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One of those was Catherine McNamara, who was told the medication was safe during pregnancy, but burst into tears when told her son Sebastian’s deformities were permanent, the Sunday Times reported.

His hands were unnaturally twisted and facing in the wrong direction, with one missing a thumb.

She blamed herself, while another victim said she had been given the drug without a safety information leaflet.

A spokesperson for NHS England said it has set up an expert group to help cut the use of valproate by women who can get pregnant in half.

Former health secretary Jeremy Hunt chairs the health and social care select committee (Picture: Getty Images) © Provided by Metro Former health secretary Jeremy Hunt chairs the health and social care select committee (Picture: Getty Images)

But Mr Hunt, who chairs the health and social care select committee, does not believe that is enough and compared the problem to the Thalidomide scandal.

He 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.

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‘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’ and 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 and their healthcare professional needs to sign an annual risk acknowledgement form, 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.

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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. We want to improve the future safety of medicines and medical devices – ensuring they are used in line with the latest evidence of best practice – and there are wider forms of redress available for those who need it.’

The review, launched in 2018 by Mr Hunt, 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.

Baroness Cumberlege made a series of recommendations and called on the Government to issue an immediate ‘fulsome apology’ on behalf of the healthcare system to the families affected.

A spokesperson for NHS England said: ‘Last year the NHS wrote to all women and girls aged between 12-55 in England on the medication to remind them of risks with the drug when pregnant and has worked with partners on a number of initiatives to support reduction in valproate risks.’

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Jeremy Hunt calls for ‘immediate fix’ to prevent avoidable harm to babies .
Call for pregnant women to be banned from taking drugA 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.

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