Epilepsy drug that left 20,000 babies disabled in UK is STILL being prescribed to pregnant mums despite warnings

AN epilepsy drug which left thousands of babies disabled in the UK is STILL being prescribed to pregnant mums, an investigation has found.

Sodium valproate has caused autism, learning difficulties and physical deformities in up to 20,000 babies in Britain.

The drug, which carries significant risks to unborn children, was given to women with epilepsy for four decades without proper warnings.

It has left families up and down the UK suffering the consequences,with some saying they still receive no information leaflets with their medication.

But despite a 2020 criticising the failure to inform women about the dangers, doctors are still not properly warning women of the risks, The Sunday Times reports.

According to the latest data, published in March, sodium valproate was prescribed to 247 pregnant women between April 2018 and September 2021.

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It means around six babies are being born in the UK every month having been exposed to the drug.

An investigation by The Sunday Times found the medication is still being dished out to women in plain packets with the information leaflets missing, or with stickers over the warnings.

The government is also refusing to compensate those affected, despite an independent review by Baroness Cumberlege concluding in 2020 that families should be given financial help.

Catherine McNamara said her son Sebastian was born with malformed hands and other disabilities after she was prescribed the drug during her pregnancy in 2011.

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She told The Times she had asked about the safety of the drug because her two older children had learning difficulties and autism.

Ms McNamara explained: “I went to the GP and said, ‘I’ve two children with quite severe learning difficulties and autism, is there any chance it could be to do with my tablets?

“The GP said no, just keep taking the tablets, everything will be fine. My consultant said the same.”

All three of her children have since been confirmed as valproate victims.

The Times also found sodium valproate is still being sent out by pharmacists without legally required patient information leaflets.

Patricia Alexander, whose two children Amélie, 12, and Joseph, 21, were both affected by sodium valproate after she was told it was safe to take while pregnant, still receives the drug in packets with no safety leaflets.

I went to the GP and said, ‘I’ve two children with quite severe learning difficulties and autism, is there any chance it could be to do with my tablets?

The GP said no, just keep taking the tablets, everything will be fine.

“There is nothing in the box but 22 tablets,” she said. “The fact I am getting the boxes like this means others are as well.”

Medical regulators in the UK were first warned of the possible dangers of the drug in 1973, but provided no patient warnings and did not commission any longer term studies into the risks.

The Department of Health and Social Care has acknowledged the matter of the drugs still being handed out in plain packaging without the appropriate warnings.

It also launched a consultation in November to recommend sodium valproate is always dispensed in the original manufacturer’s packaging “to support increased patient safety” — but the government has not yet responded.

An NHS England spokesman said it had set up an expert group to help halve the use of sodium valproate by women who can get pregnant, and warned thousands of women and girls as young as 12 of the risks.

Dr Alison Cave, chief safety officer for the Medicines and Healthcare products Regulatory Agency (MHRA) also said all women on the drug were now required to sign annual risk-acknowledgement forms together with their healthcare professional “as their circumstances regarding the risk of pregnancy may change”.

But the medicines regulator has admitted warnings are still not getting through.

The Department of Health and Social Care 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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“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.”

Sodium valproate is still a safe and effective drug for epilepsy sufferers.

These patients should not stop taking it without discussing with their doctor first.

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