Latest news with #PatientSafetyCommissioner
ITV News
2 days ago
- Health
- 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.
Yahoo
17-02-2025
- Health
- Yahoo
Mum's 20-year fight for epilepsy drug compensation
"Who will look after our children when we're no longer here? At the moment that's nobody." Catherine Cox, from Keyworth in Nottinghamshire, was one of thousands of women who took the epilepsy drug, sodium valproate, while pregnant, something which is now advised against. Her son Matthew, now 23, was born with a range of conditions, including autism, ADHD, epilepsy and several learning disabilities. At the age of 18 months, he was diagnosed with foetal valproate syndrome, indicating the medication his mother took was the cause of his problems. Mrs Cox has been campaigning for compensation ever since. It is thought thousands of children in the UK have been left with disabilities caused by valproate since the 1970s. Instructions for doctors - and, more recently, patient leaflets - say valproate should not be used during pregnancy unless there is no safer alternative and only after a careful discussion of the risks. Before undergoing fertility treatment, Mrs Cox was advised it was "fine" to continue taking valproate. "To then find out that the medication that you have taken in good faith has caused the problems your child will carry for the whole of their life is an awful thing," she told the BBC. Mr Cox has a job at a local bakery but relies heavily on his mother. "It can be a struggle at times," he said. "I do worry at times but I also worry about my mum. Obviously I love my mum." Mrs Cox told the BBC she had grown weary of a lack of action from successive governments. "We're not getting any younger. I started this when I was 31 - I'm 53 this year," she said. "I honestly think that the government want the parents to expire, because the children will not be able to fight for the redress that they need." In February 2024, a report by the Patient Safety Commissioner, Henrietta Hughes, said there was a "clear" and "urgent" need to compensate those harmed by valproate, both financially and otherwise. Dr Hughes made a series of recommendations, including a specific housing grant for valproate victims, a removal of the barriers many face in getting their special educational needs recognised, and work to issue an apology to each individual affected. More than a year has since passed, and the government is still working on a response. Mrs Cox said: "We have pulled various governments over time kicking and screaming to this point where they have acknowledged that the difficulties for up to 20,000 children were caused by this drug. "As we go on, what we need is something to make up for their loss of potential." The delays were recently raised at Prime Minister's Questions by Mrs Cox's MP, Labour's James Naish, who represents Rushcliffe. Sir Keir Starmer responded it was "obviously a really important matter". "We will provide an update on the Patient Safety Commissioner's report at the earliest opportunity to the House," the prime minister added. Naish said: "We're all working hard. The government has a huge amount on its plate. It's already dealt with big scandals such as the infected blood scandal. "We just want to make sure that this is one of those issues as well." Despite two decades of setbacks, Mrs Cox is hoping she will hear some positive news soon. "The Labour government were really, really supportive in opposition. Let's see them stand by their word," she said. "As a society we are judged by how we treat our most vulnerable and the children affected by valproate are our most vulnerable. They need that help going forward." Follow BBC Nottingham on Facebook, on X, or on Instagram. Send your story ideas to eastmidsnews@ or via WhatsApp on 0808 100 2210. Men on sodium valproate told to use contraception Epilepsy drug GP guidance 'a massive breakthrough' Epilepsy drug disabilities a 'scandal'
BBC News
17-02-2025
- Health
- BBC News
Valproate: Mum's 20-year fight for epilepsy drug compensation
"Who will look after our children when we're no longer here? At the moment that's nobody."Catherine Cox, from Keyworth in Nottinghamshire, was one of thousands of women who took the epilepsy drug, sodium valproate, while pregnant, something which is now advised son Matthew, now 23, was born with a range of conditions, including autism, ADHD, epilepsy and several learning the age of 18 months, he was diagnosed with foetal valproate syndrome, indicating the medication his mother took was the cause of his problems. Mrs Cox has been campaigning for compensation ever since. It is thought thousands of children in the UK have been left with disabilities caused by valproate since the for doctors - and, more recently, patient leaflets - say valproate should not be used during pregnancy unless there is no safer alternative and only after a careful discussion of the undergoing fertility treatment, Mrs Cox was advised it was "fine" to continue taking valproate."To then find out that the medication that you have taken in good faith has caused the problems your child will carry for the whole of their life is an awful thing," she told the Cox has a job at a local bakery but relies heavily on his mother."It can be a struggle at times," he said. "I do worry at times but I also worry about my mum. Obviously I love my mum."Mrs Cox told the BBC she had grown weary of a lack of action from successive governments."We're not getting any younger. I started this when I was 31 - I'm 53 this year," she said."I honestly think that the government want the parents to expire, because the children will not be able to fight for the redress that they need." In February 2024, a report by the Patient Safety Commissioner, Henrietta Hughes, said there was a "clear" and "urgent" need to compensate those harmed by valproate, both financially and Hughes made a series of recommendations, including a specific housing grant for valproate victims, a removal of the barriers many face in getting their special educational needs recognised, and work to issue an apology to each individual than a year has since passed, and the government is still working on a Cox said: "We have pulled various governments over time kicking and screaming to this point where they have acknowledged that the difficulties for up to 20,000 children were caused by this drug."As we go on, what we need is something to make up for their loss of potential." The delays were recently raised at Prime Minister's Questions by Mrs Cox's MP, Labour's James Naish, who represents Keir Starmer responded it was "obviously a really important matter"."We will provide an update on the Patient Safety Commissioner's report at the earliest opportunity to the House," the prime minister said: "We're all working hard. The government has a huge amount on its plate. It's already dealt with big scandals such as the infected blood scandal."We just want to make sure that this is one of those issues as well."Despite two decades of setbacks, Mrs Cox is hoping she will hear some positive news soon."The Labour government were really, really supportive in opposition. Let's see them stand by their word," she said."As a society we are judged by how we treat our most vulnerable and the children affected by valproate are our most vulnerable. They need that help going forward."
