Oxford professor says thousands of children harmed by drug used for epilepsy is a 'major scandal'
A leading professor from Oxford says 40 years of inaction led to thousands of children being harmed by a drug used to treat epilepsy.
Carl Heneghan runs the Centre for Evidence-Based Medicine and says serious failings led to generations of children suffering disabilities caused by sodium valproate.
Sodium valproate has been used for decades to save the lives of women with epilepsy, but it has also been harming babies.
If taken during pregnancy, it increases the risk of birth defects, autism, cleft palate and spina bifida.
The professor from Oxford has studied what research was available when and believes doctors and regulators failed families.
Carl Heneghan said: "I'd say with certainty it was about 1992 that the clinical evidence was quite clear - there was a more than doubling of the risk of congenital malformations.
"Yet this drug continued to be used widespread across the country for women of childbearing age."
"I think about it as a major scandal."
"If you look at the time span, there was a near sort of 40 years of inaction around the evidence of harms."
He says warning and action should have happened far sooner.
Professor Carl Heneghan from the Centre for Evidence-Based Medicine
Professor Heneghan said: "About 1 in 10 women were having congenital malformations on this drug, if they were taking sodium valproate or Epilim pregnancy.
"It's been a complete regulatory failing, a complete failing of clinical practice to act on the signals of harm."
Women who spoke to ITV Meridian say they weren't warned that their epilepsy medication risked causing birth defects in their children say they feel 'abandoned and forgotten' by the government.
Penny Johnson's son Alan was born ten years after Sarah in 1999. He has mobility problems and autism.
"There was no warnings on the box," said Penny. "Nothing said that I shouldn't take the medication before trying for a baby. There was nothing."
Penny Johnson, a mother who took sodium valproate
Penny said: "I was angry, I was upset, I felt the guilt because I took the medication.
"I mean Alan bless him, says it's not my fault, the doctors told me, but still, to me, I've done that, I've done that to him.
"And it breaks my heart."
Charities such as Epilepsy Action say as the parents of the children affected get older, the need for redress is becoming more urgent.
Chantal Spittles from the charity said: "We know that it's costing an average family around £30,000 extra a year just to be able to look after their now adult children.
"Often, many of them need 24-hour care.
"They worry about the future, and that's a scandal as well.
"You shouldn't have to worry about what's going to happen to your children. "
Mothers who took epilepsy drug that led to birth defects feel 'abandoned'
They're just worried that they are going to be left behind again and left to fall though the cracks yet again."
A major review into sodium valproate was published over a year ago and said those affected should be compensated.
A spokesperson from the Department of Health and Social Care said: "We are fully focused on how best to support patients and prevent future harm.
"The Government is carefully considering the Patient Safety Commissioner's recommendations in full."
Medical regulator the MHRA said: "Since 1974 product information for healthcare professionals has always included a warning about the risks of valproate use during pregnancy.
"In the 70s and 80s, few medicines were supplied with any printed information for patients.
"The first patient information leaflet for valproate, approved in 1989, advised patients to contact their doctor if pregnant or planning a pregnancy so risks could be discussed."
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