Oxford professor says thousands of children harmed by drug used for epilepsy is a 'major scandal'
ITV Meridian's Christine Alsford reports
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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ITV News
4 days ago
- ITV News
'Why didn't they tell us?' Mothers who took epilepsy drug that led to birth defects feel 'abandoned'
In the first of several reports, ITV Meridian's Social Affairs correspondent Christine Alsford has been speaking to Carole McNeil about her experience. Three women who 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. Carole McNeil, Penny Johnson and Jo Gamblin all had babies with a variety of problems including mobility difficulties, learning disabilities, speech problems and autism. They gave birth to their now grown up children over a sixteen year time span - but they all say they weren't told about the dangers of sodium valproate. They say they weren't given the chance to change their medication and their concerns were dismissed by doctors and other medical experts. None of them have told their stories before - but they say they can now no longer stay silent amid institutional failures and unacceptable delays in their fight for justice. Carole McNeil now lives in Bournemouth. Her daughter Sarah was born in 1989 and is now aged 35. She has mobility problems, speech difficulties and learning difficulties. She also had to have an operation for scoliosis when she was 14. Carole McNeil Carole had been on sodium valproate since the age of two. She was concerned about taking the medication while she was pregnant. "I asked if there was any side effects and was told no, you'll be fine," she said. She says she was initially told by doctors that Sarah was double jointed - but later on a five year battle showed she had sodium valproate syndrome. She's angry that information about the drug wasn't shared with patients earlier. "Why, why didn't they tell us?" "The government that knew in 1973 that there was the problem with this drug and Sarah was born in 1989, 16 years after. "It's not right. It's not right." ITV Meridian's Social Affairs correspondent Christine Alsford has been speaking to Penny Johnson about her experience. An estimated 20,000 children have been affected by sodium valproate damage - which is twice the number in the Thalidomide scandal, a drug that also caused birth defects. Women took the epilepsy medication to control their seizures but say they weren't given the opportunity to switch to alternatives and had no idea the drug increased the risk of birth defects and developmental delays. 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 She says the government needs to take urgent action to help families. "I feel very alone and abandoned," she said. "I feel forgotten. I need things put in place for my son. I'm 56 years old." Penny from Aylesbury in Buckinghamshire, believes that three miscarriages that she suffered, are also a result of the medication. One happened at 16 weeks. She added she was denied the chance to make choices. "I feel that I could have had the medication changed so easily because my epilepsy was not severe. In fact, I don't know medication now. I haven't been on medication since 2002." ITV Meridian's Social Affairs correspondent Christine Alsford has been speaking to Jo Gamblin about her experience. Parents including Jo Gamblin from Fareham in Hampshire say they've been let down by the system. "They've known for years the dangers of it," said Jo. " And to just leave women to carry on having children. I just don't understand how they can even sleep at night." Jo's son Lewis is aged 19 and was born with signs of sodium valproate syndrome and has now been diagnosed with ADHD and autism and registered as disabled. "What I really want to get across is what has happened to our children," said Jo. "They need help. "This wasn't his fault. It's not my fault. And what they seem to be forgetting is that we were given the medication to help us in the first place because we've got an illness that is life threatening and now we've got more stress. And stress is one of the biggest triggers for epilepsy." Jo Gamblin Well over a year ago a major report that set out how a redress scheme for sodium valproate should work was published. Written by the Patient Safety Commissioner, Professor Henrietta Hughes, it said there was a "clear case for redress based on the systematic healthcare and regulatory failures". Sixteen months on, there has been no response from the government, which she describes as "disappointing". "The responsibility of all government should be to keep their citizens safe and in this situation I believe patients and families have been let down by a system that hasn't focused on safety," she said. "The disjointed and dismissive nature of the health system is what led to those patients being harmed." The Department for Health and Social Care said they would provide an update "at the earliest opportunity". A spokesperson said: "We are fully focused on how best to support patients and prevent future harm. "This is a complex area of work and 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." Watch an ITV Meridian vodcast where Social Affairs Correspondent Christine Alsford speaks at length to Carole McNeil and Jo Gamblin. In 2018 new warnings were added to boxes of sodium valproate warning that the drug shouldn't be taken by pregnant women. There is also now a Pregnancy Prevention Programme in place for women under the age of 55. Sanofi, manufacturers of one of the main brands of sodium valproate called Epilim, told us: "We have always worked closely with the MHRA and fully met all our legal and regulatory obligations in relation to valproate which is an essential medicine used to treat a serious and potentially life-threatening condition. "The use of valproate in pregnancy is an incredibly complex issue that involves many different parties including government, regulators, doctors and other prescribers, pharmacists, manufacturers, patients and other people affected. "All partners in the healthcare system, including health authorities, healthcare professionals and pharmaceutical companies, have a role to play in providing information on risks and benefits of medicine to all patients who take them, consistent with scientific and medical knowledge."
ITV News
4 days ago
- ITV News
Oxford professor says thousands of children harmed by drug used for epilepsy is a 'major scandal'
ITV Meridian's Christine Alsford reports 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."
ITV News
6 days ago
- ITV News
Sodium Valproate: Everything you need to know about the risks of the drug and its history
Watch an ITV Meridian vodcast where Social Affairs Correspondent Christine Alsford speaks at length to Carole McNeil and Jo Gamblin. What is Sodium Valproate? It's a drug used to treat epilepsy. In the past it was used for bipolar disorder and migraine. What problems can it cause? Birth defects including spina bifida, cleft palette, malformations of the limbs and sexual organs, heart, kidneys, and urinary tract. Developmental delays including delayed walking and talking, poor speech and language, lower intelligence and memory problems. And there is an increased risk of autism or autism spectrum disorders and possibly ADHD. How long has the drug been given to women in England? It was first used in 1973 - but only given a licence for year for specialist centres and hospitals. In 1974 a full licence was granted on the basis that doctors were warned specifically about how it can cause birth defects or developmental abnormalities in animals. Why have women ended up taking the drug during pregnancy? Often women have been taking the drug long term to control their epilepsy and have then become pregnant without discussions about whether that medication should be reviewed or changed by their doctors before conception. In several cases women have been in contact with fertility services or GPs about their pregnancies and information and knowledge has been lacking or not passed on about the potential risks. But in other historic cases they say they have asked experts including neurologists about the safety of the drug in pregnancy and been reassured only to find their children have then been affected. For some sodium valproate is the only drug that will control their seizures. What increased risk of birth defects and other problems does it have? Around 1 in 10 babies whose mothers take valproate while pregnant will have a birth defect. Two or three babies in every 10 may have developmental is evidence children are more likely to have autism or autism spectrum disorders and possibly ADHD. Why are women speaking out about this now? In many cases they are getting older and are worried about how their children will be looked after in the future. Several have been fighting for many years for redress. There is frustration that legal cases have collapsed, reviews by the government have not resulted in action and a major report that was published well over a year ago by the Patient Safety Commissioner has not had a response from the government. The government say they are working to provide an update "at the earliest opportunity". Why hasn't sodium valproate been banned? It is a very effective drug for epilepsy which can be a life threatening condition - and for some will be the only drug that will control seizures. Since 2018 it has been banned to treat epilepsy during pregnancy unless there is no other effective treatment available. No patient should stop taking valproate without advice from a specialist. Why did it take so long for warnings about the medication to be passed on? From 1974 health professionals were warned about potential dangers but this information wasn't always passed on to women and their families. At this stage it was known that the drug caused birth defects in animals like mice at high doses. A letter to doctors from the Committee for the Safety of Mediciens in 1974 decided not to inform patients directly because it would cause "fruitless anxiety". As more studies were carried out and evidence emerged, the first patient information leaflet was introduced in 1989. This said that pregnant women and those who may become pregnant should consult their doctor - but there was no indication why. These warnings were later strengthened and became more detailed - particularly on the risk of spina bifida. It took nearly 30 years after this for warnings about the drug being taken in pregnancy to be added to boxes and pill packets (2018). The medical regulator, the MHRA, says while legislation now requires that patients be directly provided with information about their medicine, in the 70s and 80s few medicines were supplied with any printed information for patients. What safeguards are in place about taking sodium valproate now? Strips of pills have prominent pictorial warnings saying the drug shouldn't be taken in pregnancy - so do the boxes. Patient information leaflets included with the medication explain the harm it can cause - and how it must not be used in pregnancy. Women who are under 55 and taking valproate should be included in the Pregnancy Prevention Programme. This programme tightly controls who should take valproate and has to be signed off by two specialists. There is also increased awareness of the need to warn men too who are on sodium valproate as birth defects can be passed on via fathers who take the drug as well.
