Latest news with #Epilim
RTÉ News
2 days ago
- Health
- RTÉ News
Inquiry begins into prescribing of anti-epilepsy drug
An inquiry has begun into the historical prescribing of an anti-epilepsy drug which can cause birth defects if used during pregnancy. The non-statutory inquiry into the use of sodium valproate, sold under the brand name Epilim, is scheduled to last between 12 and 18 months. It is estimated over 1,000 children have been impacted in Ireland since the 1970s. The inquiry, which will be chaired by barrister Bríd O'Flaherty, will be divided into a number of strands. The first will be the review phase, which will establish a timeline of the use of the drug including information on safety and regulation. The Department of Health said the inquiry will have responsibility to request documentation from a range of stakeholders and will be obliged to record any difficulties where such requests are refused. The second phase will be made up of oral statements from affected families. These sessions will be held in private. Other phases will focus on assessing the health services' current capacity to respond to safety issues related to the use of anti-seizure medications in women. The department said necessary data regulations were passed last week in the Dáil and Seanad. Families have been campaigning for years for an inquiry to be held and have welcomed the fact that it began today. The department has previously said sodium valproate is an effective medication for some and those taking it should not make any changes to treatment without first discussing it with their doctor. The department has also previously said while sodium valproate is an effective and essential treatment for some patients, it can cause birth defects, neurodevelopmental disorders and autism in children whose mothers take such medicines during pregnancy.
ITV News
19-06-2025
- Health
- 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."
Irish Examiner
11-06-2025
- Health
- Irish Examiner
One year later, work on epilepsy medication inquiry is yet to begin
Work has yet to begin on an inquiry into the prescribing of epilepsy medicine, a year after a chairperson for the probe was appointed — on a 12-month contract. Affected families want to know what has caused the delay to the inquiry beginning its work in full. The role of chairperson was advertised early last year, and when the inquiry was publicly launched and the chairwoman confirmed in June 2024, it was understood that a certain amount of time was needed to lay the groundwork. At the time, then health minister Stephen Donnelly said work would begin 'within weeks'. This led families to understand the chairwoman, barrister Brid O'Flaherty, would be supported to begin work quickly. Recruitment notices advised a chairperson would 'sign a contract for services for a period of 12 months with the possibility of extending by a further six months'. Asked whether this contract is being extended now, a department spokeswoman said they cannot comment on individual contracts, adding: However, once the inquiry formally commences, a time commitment of between 12 and 18 months is envisaged for the chair to conduct an independent, fair, and rigorous process. Ms O' Flaherty has met patient group the Organisation for Anticonvulsant Syndromes (OACS) Ireland for initial discussions. However they do not know when her wider work with individual families can start. Solicitor for the group, Ciara McPhillips, partner at Michael Boylan LLP, said the department's stance raises more questions than it answers. 'The questions now point back to the department, did they appoint the chair prematurely before they had their groundworks done, or has some unforeseen problem arisen,' she said. The department previously cited work on data regulations as one reason for the delays. However Ms McPhillips said OACS Ireland were told in October 2023 this work had already started. The families have requested a meeting with minister Jennifer Carroll MacNeill but are yet to hear when this might happen. They have questions. This is why we need to meet with the minister to understand and get answers as to what is the hold-up. Ms O'Flaherty was unavailable for interview, a spokeswoman said. She added: "she has conveyed that the public-facing elements of the inquiry will commence shortly after the Department has finalised the regulations.' No date was given for when this might be. They confirmed she has been working, saying she did 'significant work' on practical arrangements for when the inquiry starts. The HSE now advises girls and women not to get pregnant while taking this medication, brandname Epilim containing Valproate, and to discuss pregnancy plans with their doctors. Read More Parents finding it harder to look away from scandals at CHI — if they ever could
Irish Examiner
02-06-2025
- Health
- Irish Examiner
'No faith in the system' as mother waits year for epilepsy drug inquiry
Debbie Adams has been waiting a year to address an inquiry into the prescribing of epilepsy medicine containing Valproate to pregnant women. Her daughters, aged 13 and 11, were diagnosed with Fetal Valproate Syndrome (FVS) in 2020. This came after years of diagnosis for individual symptoms. Their youngest daughter also had double surgery for hip dysplasia at Temple Street Hospital. A letter advising that she needs a review as part of investigations into these surgeries has only added to the worries for Debbie and her husband. Last June, an inquiry was launched into the prescribing of valproate, which can cause serious birth defects and development disorders. Families were told the inquiry would begin "within weeks" but there is still no sign of it starting. Debbie chose not to attend the launch event. 'I wanted to get excited but the pessimistic side of me said 'how long are we going to be waiting?' and that's probably why I didn't go," she said. One year on, she is just tired. 'I've no faith in the system,' she said. This should not have happened. This has changed the trajectory of our family's life. She wants answers: why does she have a wall-planner in the kitchen covered with therapy appointments? 'The children have grown up like this and they think everybody's life is like this. We had different dreams for them,' she said, tearfully. The HSE now advises if a woman or girl becomes pregnant while taking valproate (brand name Epilim), their baby is at risk of serious birth defects and developmental and learning disorders. Debbie, who has been taking Epilim to control her epilepsy seizures, recalled speaking with her neurologist when pregnant with Isobelle. Debbie Adams took Epilim to control her epilepsy seizures. Picture: Moya Nolan 'I was warned about spina bifida and cleft lip and palate; they were the two things that I was aware of,' she said. She was relieved early scans showed no signs of these but does not recall discussion of wider risks under Fetal Valproate Syndrome (FVS). Isobelle and her sister Isla, who uses a mobility scooter, faced similar challenges as babies. 'My youngest was showing all the same delays — not crawling, not walking, not speaking, and I said this can't be normal to happen twice in the one house,' she said. She was reassured during a neurology appointment about any potential links to her medication. But soon afterwards, while in Portugal at a family wedding, she saw a report from the British parliament on Sky News. Devastating information They were talking about FVS, and she recalls racing out to find her husband to share the devastating information. Returning home, they met up with Karen Keely, founder of patient group OACS Ireland, which represents more than 130 families. 'It's a horrible reality,' she told the Irish Examiner,sitting in Karen's kitchen. 'You live in fear for them [the children] for when you're gone.' She pointed out that despite pledges to support affected families, they still had to battle long waiting lists and delays for therapies. She is aware of recent High Court cases taken by other families struggling for answers. 'For me that was like validation, it's happened, acknowledgement somewhere has taken place,' she said. Ms Keely said families feel "absolutely disgusted' by the delays to the inquiry. She said people want 'acknowledgement this has happened; harm has happened'. The Department of Health said when work on data protection issues are finished, 'it is anticipated that the public-facing elements of the inquiry will commence shortly thereafter". No definitive timeframe was given.
Daily Mail
29-05-2025
- Health
- Daily Mail
EXCLUSIVE My four children have all been left disabled after doctors told me I HAD to take this drug during pregnancy to avoid killing them
A mother-of-four whose children have all been left with disabilities after doctors encouraged her to take a drug during pregnancy without warning her of the risks has heartbreakingly revealed how her daughter is a 'prisoner in her own bedroom'. Karen Buck, 53, was diagnosed with epilepsy when she was 12 years old and initially had two drugs pumped into her that completely 'zombified' her and left her feeling like she was walking around 'asleep'. The devastating trauma she has faced throughout her life began shortly after - when a group of men took advantage of her vulnerability and gang raped her at the age of 13. Numb and sedated by the drugs, she was moved onto Epilim - one of the leading sodium valproate drugs to control epilepsy seizures. But this would tragically mark the start of another four decades of torture. Despite it being known since the 1970s that valproate can harm babies in the womb, Ms Buck and countless other expectant mothers have been prescribed the drug over the last five decades without being warned of the risk of birth defects. An estimated 20,000 children were exposed to the epilepsy drug while in the womb and many are now adults living with neurodevelopmental disorders such as autism and ADHD. While Epilim initially worked well for Ms Buck, her children, who are now in their 20s and 30s, were all later diagnosed with foetal valproate syndrome after doctors told her to carry on taking it - even upping her dosage - during pregnancy. Her third child, Bridget, was born with severe brain damage and spina bifida, is paralysed from the waist down and has so many complex disorders that she has been referred to as the 'world's worst affected child'. In an emotional interview with MailOnline, Ms Buck, from Stanmore, north-west London, said: 'Bridget is paralysed, she's brain damaged. She's bed bound and she's a prisoner in her own room.' Bridget, who is now 27, must be surrounded by oxygen tanks as she has Lennox-Gastaut syndrome, meaning she constantly has seizures which can cause her to stop breathing. Ms Buck has always cared for her daughter 24/7, even from a young age when she decided to take her out of school because she was being abused so badly. The mother-of-four has revealed how not only did doctors not warn her of the risks of taking Epilim while pregnant, they made sure she stayed on it and increased her dosage so she 'wouldn't kill her baby by having a seizure'. Ms Buck is one of thousands of parents across the world who are fighting for compensation. Her other three children, Josephine, 36, John, 34, and Christine, 22, have all faced individual battles as a result of being harmed by valproate, Ms Buck says. Josephine has spinal issues, crystallisations of the joint, nerve damage, polycystic ovaries and small hands. John has a twisted oesophagus, dyslexia, a hiatal hernia, and sleep hyponoia. And Christine has a heart condition and problems with her ears and back. But it was Ms Buck's pregnancy with Bridget that was the most complicated. At one stage, the foetus was in her ovary and her tubes - before eventually moving around to her womb. During the pregnancy, she started being 'violently sick' to the point it was inducing seizures. Pictured is Bridget Buck as a young baby. She was born with several defects and is now bed bound at age 27 Ms Buck explained: 'They increased my dosage while I was pregnant and I questioned it. I said, "I'm being violently sick. Is it wise to put my medication up? Couldn't you give me something for the sickness, rather than the seizures?" 'And I'll never forget this, they then said to me that if you have a seizure, you will kill your baby, so it's important for us to give you the medication.' Ms Buck says Bridget and her other children have been 'deprived' of a normal life as a result of her not being warned of the risk of birth defects. Speaking about Bridget's day-to-day life, she said: 'Every day is in the bed. Every day is in the same routine. It's get up, wash her, change her, medicate her, entertain her, feed her. If she has a seizure, you have to be on the ball. 'You've got to give her oxygen, emergency medication.' Ms Buck says the list of disorders that her daughter has is so long that she is known as 'the world's worst affected child'. 'She's paralysed from the waist downwards. She can't eat normal foods. She can't pick up a knife and fork and eat food. 'She couldn't pick up an orange and start eating it because the skin would choke her. 'If she's feeding and she starts coughing it's gone into the wrong part of her body, it's gone into her lungs.' Ms Buck was yet again rocked by another battle when she was diagnosed with cancer. She has since brought in a carer to assist her in looking after Bridget. In February 2024, families whose lives have been ruined by the scandal were given a fresh glimmer of hope when England's patient safety commissioner called on the Government to compensate those affected. Dr Henrietta Hughes recommended a £100,000 payout after describing the drug's damage as a 'bigger scandal than thalidomide', referring to the morning sickness drug which led to thousands of mothers giving birth to disabled babies. Ministers said they would consider and respond to compensation recommendations but a deafening silence has left mothers fearing they have once again been forgotten - as they fight for compensation while they are still alive. The Hughes report came after Baroness Cumberlege published a lengthy review into sodium valproate and two other medical interventions in 2020, which highlighted the denial and dismissal of patient concerns. The Government issued an official apology in 2021, but the mothers fighting for justice want 'action not words'. And while countries such as France have started paying out victims, the UK Government is still not acting. Speaking about the lack of urgency to redress affected families, Ms Buck said: 'I feel disgusted by the authorities. I feel disgusted by the Government. I feel disgusted by the regulators. I feel disgusted by the NHS neurologists. And I feel disgusted by the drug company because they should have put it in place. 'I feel they are not taking accountability to put things right. If they explained to me this drug could cause damage to my children I would have had my tubes tied right from the start, not afterwards so that I wouldn't have any more. I wouldn't be able to cope looking after more children. 'Bridget is the world's worse and it's taken a lot of me.' Speaking of the scale of the scandal, she added: 'It's bigger than thalidomide. It's bigger than the contaminated blood scandal. It's bigger than the Post Office scandal, and it's getting bigger.' Ms Buck continued: 'I've been through the courts, it failed. I've witnessed the Cumberlege report, that went on for five years and then now the Hughes report, nothing's come. 'Do I trust them? No. They've not listened to all the family stories. I listen day in, day out, to the families. Nobody's listening to them. Until they show me something for all my families that I'm listening to, then I will say, OK.' 'You need to practice what you preach. Don't throw out easy apologies. 'You have done damage to all these people. You are accountable for this and you've let all these women down, that's what makes me angry.' Ms Buck says she has been let down throughout her life, including when she was prescribed drugs that 'zombified' her as a 12-year-old. She was initially diagnosed with epilepsy due to the trauma she had suffered when she was a young girl, when her parents split up and her mother's new boyfriend started abusing her. The initial epilepsy drugs left her feeling like a 'zombie' and she wanted to stay away from her mother's home because she was living with someone abusing her. She was only on those drugs for three to six months, but during that time she was gang raped by men who preyed on her vulnerability and sleepiness. Recalling the traumatising ordeal, she said: 'I was only young, I was probably 12 or 13, very young. I actually kept that all to myself, I was so scared. The only person I told was a doctor but he just overlooked it like I was a child seeking out attention. He said, "It was just a drug making you hallucinate, we'll put you on a different drug". I'm not imaging this, these things happened to me. Ms Buck was then put on Epilim but throughout all four pregnancies was never told there were any risks. 'I should have had more guidance, I should have had the support,' she said. 'They should have given me a choice, they didn't tell me anything about what this drug was capable of doing. 'It is appalling the way we have been treated.' Campaigners have proven that concerns over sodium valproate, commonly known by brand names Epilim, Episenta and Depakote, were first identified in the 1970s but the drug only started to be restricted by the government in 2018. They ruled that valproate must not be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme. It came after the Medicines and Healthcare Products Regulatory Agency said up to four in 10 babies were at risk of development disorders if the drug was taken during pregnancy and and one in 10 at risk of birth defects. A drug safety update in January 2024 stated that women and men under 55 should not be prescribed the drug unless two separate specialist agree there is no other effective treatment. Jo Cozens, the Chairperson of Organisation for Anti-Convulsant Syndrome (OACS Charity) who support families harmed by valproate, told MailOnline: 'I'm extremely disappointed frustrated beyond words.' Ms Cozens, who has requested urgent meetings with the Government but has not heard back, said: 'Not even an acknowledgement is so insulting to families.'
