An epilepsy drug that disabled thousands of babies in the UK is STILL being prescribed to pregnant mothers, a research has found.
sodium valproate has caused autism, learning disabilities and physical deformities in up to 20,000 babies in the UK.
The drug, which poses significant risks to unborn children, was given to women with epilepsy without proper warning for four decades.
Families across the UK are suffering the consequences, and some say they are still not receiving information leaflets with their medicines.
But despite a 2020 criticism that women aren’t told about the dangers, doctors still don’t properly warn women about the risks. The Sunday Times reports.
According to the latest data released in March, sodium valproate was prescribed to 247 pregnant women between April 2018 and September 2021.
This means around six babies are born in the UK every month who have been exposed to the drug.
An investigation by The Sunday Times found that the drug is still being distributed to women in plain packs with either no information leaflets or stickers over the warnings.
The government also refuses to compensate those affected, although an independent review by Baroness Cumberlege in 2020 concluded that families should receive financial help.
Catherine McNamara said her son Sebastian was born with deformed hands and other disabilities after she was prescribed the drug during her pregnancy in 2011.
She told the Times she asked about the drug’s safety because her two older children had learning disabilities and autism.
Ms McNamara explained: “I went to the GP and said, ‘I have two children with pretty severe learning disabilities and autism, is there any chance it has to do with my pills?
“The GP said no, just keep taking the pills, you’ll be fine. My doctor said the same.”
All three of their children have since been confirmed as valproate victims.
The Times also found that sodium valproate is still being mailed out by pharmacists without any package inserts required by law.
Patricia Alexander, whose two children Amélie, 12, and Joseph, 21, were both affected by sodium valproate after being told it was safe to take during pregnancy, is still receiving the drug in packs with no leaflet.
I went to the GP and said, ‘I have two children with fairly severe learning disabilities and autism, is there any chance it could be my pills?
The family doctor said no, just keep taking the pills, everything will be fine.
“There’s nothing in the box but 22 pills,” she said. “The fact that I get the boxes like this means others are too.”
Medical regulators in the UK were first warned of the drug’s potential dangers in 1973, but did not issue patient warnings or commission longer-term studies into the risks.
The Department of Health and Social Care has acknowledged the issue that the drugs are still being dispensed in plain packaging without the appropriate warnings.
In November it also launched a consultation to recommend always dispensing sodium valproate in the manufacturer’s original packaging “to increase patient safety” – but the government has yet to act.
A spokesman for NHS England said he had set up an expert group to halve the use of sodium valproate by women who could become pregnant and warned thousands of women and girls as young as 12 of the risks.
dr Medicines and Healthcare Products Regulatory Agency (MHRA) Chief Safety Officer Alison Cave also said that all women taking the drug are now required to sign annual risk acknowledgment forms with their doctor, “depending on their circumstances in relation to.” the pregnancy risk change”.
But the drug agency 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 most of the recommendations in Baroness Cumberlege’s report.
“We want to improve the future safety of medicines and medical devices – by ensuring they are used in accordance with the latest best practice knowledge – and there are broader forms of redress for those who need them.”
Sodium valproate is still a safe and effective medication for epilepsy patients.
These patients should not stop taking it without first talking to their doctor.
https://www.thesun.ie/health/8665598/epilepsy-drug-disabled-babies-still-prescribed/ Epilepsy drug that disabled 20,000 babies in Britain STILL being prescribed to pregnant mothers despite warnings