Latest news with #FetalValproateSyndrome
Irish Examiner
3 days ago
- Health
- Irish Examiner
Families criticise delays to inquiry into epilepsy drug valproate
Families have criticised inordinate delays to the opening of an inquiry into the prescribing of valproate to pregnant women for epilepsy. Families affected by the prescribing of sodium valproate, which can cause serious birth defects and development disorders, were told last year that the inquiry would begin "within weeks" but there is now no timeline of it starting. The Department of Health has blamed the delays on data protection issues, but Ciara McPhillips, solicitor for the patients' advocacy group OACS Ireland, said: 'It seems incredible that it is taking so long. In October 2023, when the Department of Health was seeking to appoint a chairperson they advised OACS in writing that they were already working on the necessary data protection framework. 'And yet here we are 20 months later and 12 months on from the appointment of a chair and the inquiry has not commenced because of data regulations.' Ms McPhillips, partner with Micheal Boylan LLP, said signing off on data regulations is the responsibility of the health minister. 'We now understand, on foot of recent parliamentary questions, and a direct email from the minister, the regulations are with an arm of the Attorney General's office and that they are being worked on,' she said. Sinn Féin TD Rose Conway Walsh will now raise the delay in the Dáil. 'I absolutely share the frustrations,' she said. 'There is no explanation whatsoever for why it should take this long. It is really just putting the parents through more excruciating anxiety and pain, and these parents have suffered enough already.' Debbie Adams, whose two daughters, aged 13 and 11, live with Fetal Valproate Syndrome said: 'I've no faith in the system. 'This should not have happened. This has changed the trajectory of our family's life.' A department spokeswoman said regulations under the Data Protection Act 2018 are required to give a robust legal basis to the inquiry, including for data protection. The statutory instruments are being drafted 'as a priority', she said. 'When these have been finalised, it is anticipated that the public facing elements of the inquiry will commence shortly thereafter,' she said.
Irish Examiner
3 days ago
- 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.'
