Latest news with #Valproate
Daily Record
16-07-2025
- Health
- Daily Record
Primodos campaigners have said the government is failing women five years on from a review into the scandal
Five years after an independent review found regulators failed and were responsible for 'avoidable harm' campaigners say they are still waiting for justice. Campaigners who blame hormone pregnancy test for harming their unborn babies have said the government is failing women five years on from a review into the scandal. Primodos was taken off the market in 1978 – after 1.5million women had taken it. A 2020 independent review, First Do No Harm, found regulators failed and were responsible for 'avoidable harm'. How the NHS responded to fears over Primodos as well as pelvic mesh – linked to chronic pain – and anti-epilepsy drug sodium valproate were also reviewed. Five years on, campaigners are still waiting for justice. Wilma Ord, 77, of Livingston, took Primodos in 1970. Her daughter Kirsteen, 54, is deaf, severely asthmatic and has cerebral palsy. She said: 'Families can't wait any longer for justice, help or support.' Marie Lyon, of the Association for Children Damaged by Hormone Pregnancy Tests, added: 'The IMMDS review concluded Primodos should have been removed in 1967. It was removed in 1978, due to failures of the UK regulator to acknowledge hundreds of warnings they had received since 1958 of concerns about severe adverse effects on unborn babies. 'Since the report, 61 of our members have died without receiving justice. How can government bodies be so inhuman as to delay justice in the knowledge many of our families are elderly.' Campaigner group Sling the Mesh accused governments of 'dragging their feet'. It said there had been no audit to gauge the harm caused by mesh or compensation and few recommendations had been implemented. The group's Kath Sansom said: 'The institutional inertia amplifies the suffering – especially the lack of compensation for harm caused to thousands of women who innocently trusted their doctor they were receiving a safe treatment.' Sharon Hodgson, chair of the All-Party Parliamentary Group on First Do No Harm – Mesh, Primodos, Valproate said: 'This little progress is hugely disappointing.' In 2023, Primodos campaigners lost a High Court battle for compensation – leaving the claimants potentially liable for costs. Manufacturer Schering, now part of Bayer, has denied a link. Expressing sympathy with those who believe they suffered following the use of hormone pregnancy tests and pelvic mesh, the Department of Health and Social Care said: 'The government is considering the Patient Safety Commissioner's recommendations in full.' Bayer said: 'Bayer maintains that no significant new scientific knowledge has been produced that would call into question the validity of the previous assessment of there being no link between the use of Primodos and the occurrence of such congenital anomalies.'
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.
