Latest news with #MHRA
The Guardian
5 hours ago
- Health
- The Guardian
NHS manager ordered to stop selling ‘sleep drug-laced' children's gummies
An NHS manager has been stopped from selling children's gummies allegedly laced with undeclared levels of a prescription-only sleeping drug, the Guardian can reveal. Magnesium glycinate gummies for children who have trouble sleeping have been sold since March last year by Nutrition Ignition, an Epsom-based company owned by Sally Westcott, whose other job is a clinical therapy lead at Epsom and St Helier NHS trust. The Chinese-manufactured gummies are advertised as 'a natural way to help your child sleep better' and are described by Westcott on Facebook as 'especially beneficial in children with ADHD and autism'. But the adverts and the packaging do not reveal that the raspberry-flavoured sweets allegedly contain significant levels of melatonin, a hormone used for treating sleep problems that is only available in the UK if prescribed by a doctor. This week the drug regulator ordered Westcott to remove the gummies from her company's website and from the online retailer Amazon while it investigates. But the product remains available on eBay. Westcott said she was complying with the investigation and denied knowingly selling a prescription-only substance. The Medicines and Healthcare products Regulatory Agency (MHRA) was alerted to the gummies by two mothers who had bought the product online for their children. Last week the Guardian was able to buy a tub of 60 gummies for £19.49, including postage and packing, via Amazon without a prescription. They came with glowing five-star online reviews. One parent of a sleep-deprived child described the gummies as a 'godsend', another as 'magic'. The mothers, one a photographer and the other working in fintech, who both want to remain anonymous, had a hunch that the gummies contained more active ingredients than were listed on the label. Their suspicions were heightened when their young children, one of whom has been diagnosed with attention deficit hyperactivity disorder and the other who is suspected of having ADHD and autism, fell asleep only 30 minutes after eating the gummies. The women commissioned an independent company, Supplement Factory, to analyse the gummies. Its report, which the Guardian has seen, said they contained undeclared, but pharmacologically relevant, levels of melatonin. Each gummy contained 0.53mg of melatonin, the analysis estimated. The recommended starting dose for children is 0.5mg. Supplement Factory concluded that the inclusion of melatonin was unlawful as it breached the human medicines regulations 2012. 'A single gummy may sedate a child without clinical oversight,' Supplement Factory's report concluded. The mothers sent the report to the MHRA earlier this month. Amazon was also notified. This week the gummies were taken offline while the MHRA investigates. A spokesperson for the MHRA said: 'Patient safety is our top priority. In the UK, melatonin is an authorised medicine, and any product containing it as an ingredient is likely to be classified as a medicine. 'If a product falls under the definition of a medicine, it must hold a marketing authorisation ('licence') in order to be legally sold and supplied in the UK, unless covered by a special exemption.' It added: 'We take the reports very seriously and can confirm we are investigating these products further to determine what appropriate action is required. We are unable to comment further on the details of this investigation as it is ongoing.' In a statement Westcott said: 'We take any concerns regarding product safety, regulatory compliance and consumer trust extremely seriously. 'We are currently reviewing the information you have provided regarding the magnesium glycinate gummies. We have initiated an investigation into the matter in order to properly understand the facts and are in the process of further independent scientific testing of our products. 'Nutrition Ignition is a small business and has never knowingly sold products containing undeclared ingredients and we only work with manufacturers who meet third-party assured industry standards; specifically NSF [National Science Foundation] certification of conformity.' The photographer said: 'It's horrifying to read those reviews about children falling to sleep in minutes, when you know the reality of what's happening. It is scandalous that you can buy prescription drugs for children over the internet in this way. 'This case shines a light on how unregulated this industry is, and calls into question Amazon's responsibility in allowing misleading and potentially dangerous products being marketed and sold to the parents of children.' Her friend said: 'I feel deeply concerned about what has been uncovered. Melatonin is a prescribed medicine in the UK and parents/carers need to be made fully aware of what they are feeding their children.' She added: 'My daughter is diagnosed with ADHD and has been taking medication to manage. To assist with sleep at night, her doctor prescribed melatonin, which luckily she wasn't taking because along with the magnesium gummies, it could have been at a dangerous level in her system. The fact that the supplements market appears to be unregulated and being sold on Amazon with false claims is really worrying.' Melatonin gummies are available in China, the US and in some European countries without prescription despite doubts about their long-term safety. In the UK a hidden market has developed for melatonin gummies, particularly among parents of neurodivergent children. The ready availability of melatonin online has alarmed health experts who say its long-term health effects on children are unknown.
Yahoo
18 hours ago
- Health
- Yahoo
Weight loss jabs linked to potentially fatal side effects, says new report
Hundreds of people have reported problems with their pancreas linked to taking weight loss and diabetes jabs, prompting health officials to launch a new study into side effects. Some cases of pancreatitis reported to be linked to GLP-1 medicines (glucagon-like peptide-1 receptor agonists) have been fatal. Data from the medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), shows that since the drugs were licensed there have been hundreds of cases of acute and chronic pancreatitis among people taking GLP-1 medicines. The new weight management medication 'Tirzepatide' (brand name Mounjaro®) is shortly being made available to NHS patients to support weight loss. Access is prioritised for those with the greatest clinical need. You can find out more at: — NHS Cheshire and Merseyside (@NHSCandM) June 24, 2025 This includes: 181 reported cases of acute and chronic pancreatitis linked to tirzepatide – the active ingredient for Mounjaro. Five people died. 116 reported reactions of this kind linked to liraglutide, one of which was fatal. 113 cases of acute and chronic pancreatitis linked to semaglutide – the active ingredient for Ozempic and Wegovy. One person died. 101 reported reactions of this kind linked to exenatide, three people died. 52 reported reactions of this sort linked to dulaglutide and 11 reported reactions lixisenatide. No fatalities were linked to either drug. These cases are not confirmed as being caused by the medicines, but the person who reported them suspected they may be. Review your ICB's local policy about treating patients with tirzepatide (Mounjaro) for weight management in a primary care setting and visit: — We are Primary Care (@PrimaryCareNHS) June 27, 2025 Nonetheless, Yellow Card Biobank project, launched by the MHRA and Genomics England, will see researchers examine whether cases of pancreatitis linked to GLP-1 drugs may be influenced by peoples genetic makeup. The MHRA is calling for people who are taking GLP-1 medicine who have been admitted to hospital due to acute pancreatitis to submit a report to its Yellow Card scheme. When a Yellow Card report is received, the MHRA will contact patients to ask if they would be willing to take part in the study. Patients will be asked to submit more information and a saliva sample which will be assessed to explore whether some people are at a higher risk of acute pancreatitis when taking these medicines due to their genes. GLP-1 agonists can lower blood sugar levels in people living with type 2 diabetes and can also be prescribed to support some people with weight loss. 🧵Weight loss jab roll out 'positive for patients' but with implications for general practice that must be considered. Our Chair Kamila Hawthorne has featured widely in the national press and broadcast media responding to the phased roll-out of Mounjaro prescriptions by NHS… — Royal College of General Practitioners (@rcgp) June 23, 2025 Chronic stress and poor sleep are major weight loss blockers. Stress increases cortisol, a hormone linked to fat retention, especially around the abdomen. Sleep deprivation increases ghrelin (hunger hormone) and decreases leptin (fullness hormone), making you more likely to overeat and less likely to move. You're also more impulsive and less motivated when sleep-deprived, making it harder to stick to your diet and exercise routine. As a solution, prioritise stress management techniques (like mindfulness or journaling), and aim for 7-9 hours of sleep per night. Medical issues such as PCOS, diabetes, hypothyroidism, or insulin resistance can all interfere with weight loss. Similarly, certain medications (like antidepressants or steroids) may cause weight gain or inhibit fat loss. If weight loss stalls despite doing everything right, consult your GP to rule out or address any underlying conditions. If you have a known medical condition, it's important to stay up to date with your routine reviews and inform your GP or specialist about any weight loss treatments you're using. Regular follow-up helps ensure your treatment plan remains safe and effective. More Mounjaro news... Who is eligible for Mounjaro on the NHS? Urgent holiday warning for Mounjaro users issued Mounjaro warning as summer temperatures rise Recent estimates suggest that about 1.5 million people in the UK are taking weight loss jabs. Health officials have suggested that they can help to turn the tide on obesity, but have stressed they are not a silver bullet and do come with side effects. Most side effects linked to the jabs are gastrointestinal including nausea, constipation and diarrhoea. And the medical regulator recently warned that Mounjaro may make the oral contraceptive pill less effective in some patients. Dr Alison Cave, MHRA's chief safety officer, said: 'Evidence shows that almost a third of side effects to medicines could be prevented with the introduction of genetic testing, it is predicted that adverse drug reactions could cost the NHS more than £2.2 billion a year in hospital stays alone. 'Information from the Yellow Card Biobank will help us to better predict those most at risk of adverse reactions – enabling patients across the UK to receive the safest medicine for them, based on their genetic makeup. 'To help us help you, we're asking anyone who has been hospitalised with acute pancreatitis while taking a GLP-1 medicine to report this to us via our Yellow Card scheme. 'Even if you don't meet the criteria for this phase of the Biobank study, information about your reaction to a medication is always extremely valuable in helping to improve patient safety.' Professor Matt Brown, chief scientific officer of Genomics England, said: 'GLP-1 medicines like Ozempic and Wegovy have been making headlines, but like all medicines there can be a risk of serious side effects. 'We believe there is real potential to minimise these with many adverse reactions having a genetic cause. 'This next step in our partnership with the MHRA will generate data and evidence for safer and more effective treatment through more personalised approaches to prescription, supporting a shift towards an increasingly prevention-focused healthcare system.'
Globe and Mail
18 hours ago
- Health
- Globe and Mail
Novo Nordisk Stock (NVO) Inches Higher Despite More U.K. Weight Jab Concerns
Shares in pharmaceutical giant Novo Nordisk (NVO) edged higher today despite more pressure from health officials in the U.K. about the safety of weight-loss drugs. Confident Investing Starts Here: Pancreas Link The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) said today that it will investigate whether there is a link between weight-loss injections and acute inflammation of the pancreas. Indeed, they are asking people on weight-loss drugs who have been hospitalized by acute pancreatitis to get in touch. This comes after data from MHRA which showed that since the drugs were licensed, there have been hundreds of reported cases of acute and chronic pancreatitis among people taking GLP-1 medicines. That includes 113 cases and one death linked to semaglutide, which is the active ingredient in Novo Nordisk's Wegovy and Ozempic weight-loss injections. Meanwhile, 181 cases, with five deaths, were reported linked to tirzepatide, which is the active ingredient in Eli Lilly's (LLY) rival Mounjaro treatment. MHRA chief safety officer Dr Alison Cave said the aim was to 'better predict those most at risk of adverse reactions.' Think Twice This follows a warning earlier this month from the MHRA to pregnant women that it is unclear whether weight-loss injections could harm unborn babies. Russ Mould, investment director at AJ Bell, said this regular commentary on the side effects of injectable weight-loss drugs could make some patients think twice about using them. 'Reports of pancreas-related illnesses in a tiny number of cases could yet attract regulatory scrutiny,' he added. In the UK, the injections are only available through the state-run National Health Service, but people are still accessing them via sellers on social media or beauty salons. The demand is expected to be there. Globally, about 3.8 billion people over 25 and just under 750 million children and young people will be overweight or obese by 2050. Is NVO a Good Stock to Buy Now? On TipRanks, NVO has a Moderate Buy consensus based on 4 Buy, 3 Hold and 1 Sell rating. Its highest price target is $142.56. NVO stock's consensus price target is $94.79 implying a 40.32% upside. See more NVO analyst ratings
Leader Live
19 hours ago
- Health
- Leader Live
Weight loss jabs linked to potentially fatal side effects
Some cases of pancreatitis reported to be linked to GLP-1 medicines (glucagon-like peptide-1 receptor agonists) have been fatal. Data from the medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), shows that since the drugs were licensed there have been hundreds of cases of acute and chronic pancreatitis among people taking GLP-1 medicines. The new weight management medication 'Tirzepatide' (brand name Mounjaro®) is shortly being made available to NHS patients to support weight loss. Access is prioritised for those with the greatest clinical need. You can find out more at: This includes: These cases are not confirmed as being caused by the medicines, but the person who reported them suspected they may be. Review your ICB's local policy about treating patients with tirzepatide (Mounjaro) for weight management in a primary care setting and visit: Nonetheless, Yellow Card Biobank project, launched by the MHRA and Genomics England, will see researchers examine whether cases of pancreatitis linked to GLP-1 drugs may be influenced by peoples genetic makeup. The MHRA is calling for people who are taking GLP-1 medicine who have been admitted to hospital due to acute pancreatitis to submit a report to its Yellow Card scheme. When a Yellow Card report is received, the MHRA will contact patients to ask if they would be willing to take part in the study. Patients will be asked to submit more information and a saliva sample which will be assessed to explore whether some people are at a higher risk of acute pancreatitis when taking these medicines due to their genes. GLP-1 agonists can lower blood sugar levels in people living with type 2 diabetes and can also be prescribed to support some people with weight loss. 🧵Weight loss jab roll out 'positive for patients' but with implications for general practice that must be considered. Our Chair Kamila Hawthorne has featured widely in the national press and broadcast media responding to the phased roll-out of Mounjaro prescriptions by NHS… Chronic stress and poor sleep are major weight loss blockers. Stress increases cortisol, a hormone linked to fat retention, especially around the abdomen. Sleep deprivation increases ghrelin (hunger hormone) and decreases leptin (fullness hormone), making you more likely to overeat and less likely to move. You're also more impulsive and less motivated when sleep-deprived, making it harder to stick to your diet and exercise routine. As a solution, prioritise stress management techniques (like mindfulness or journaling), and aim for 7-9 hours of sleep per night. Medical issues such as PCOS, diabetes, hypothyroidism, or insulin resistance can all interfere with weight loss. Similarly, certain medications (like antidepressants or steroids) may cause weight gain or inhibit fat loss. If weight loss stalls despite doing everything right, consult your GP to rule out or address any underlying conditions. If you have a known medical condition, it's important to stay up to date with your routine reviews and inform your GP or specialist about any weight loss treatments you're using. Regular follow-up helps ensure your treatment plan remains safe and effective. More Mounjaro news... Recent estimates suggest that about 1.5 million people in the UK are taking weight loss jabs. Health officials have suggested that they can help to turn the tide on obesity, but have stressed they are not a silver bullet and do come with side effects. Most side effects linked to the jabs are gastrointestinal including nausea, constipation and diarrhoea. And the medical regulator recently warned that Mounjaro may make the oral contraceptive pill less effective in some patients. Dr Alison Cave, MHRA's chief safety officer, said: 'Evidence shows that almost a third of side effects to medicines could be prevented with the introduction of genetic testing, it is predicted that adverse drug reactions could cost the NHS more than £2.2 billion a year in hospital stays alone. 'Information from the Yellow Card Biobank will help us to better predict those most at risk of adverse reactions – enabling patients across the UK to receive the safest medicine for them, based on their genetic makeup. 'To help us help you, we're asking anyone who has been hospitalised with acute pancreatitis while taking a GLP-1 medicine to report this to us via our Yellow Card scheme. 'Even if you don't meet the criteria for this phase of the Biobank study, information about your reaction to a medication is always extremely valuable in helping to improve patient safety.' Professor Matt Brown, chief scientific officer of Genomics England, said: 'GLP-1 medicines like Ozempic and Wegovy have been making headlines, but like all medicines there can be a risk of serious side effects. 'We believe there is real potential to minimise these with many adverse reactions having a genetic cause. 'This next step in our partnership with the MHRA will generate data and evidence for safer and more effective treatment through more personalised approaches to prescription, supporting a shift towards an increasingly prevention-focused healthcare system.'
STV News
21 hours ago
- Health
- STV News
What is acute pancreatitis and is it a side effect of weight-loss jabs?
Health experts are investigating the risk of acute pancreatitis from injections for weight loss jabs such as Ozempic, Mounjaro, and Wegovy. Patients have reported being hospitalised with inflammation of the pancreas suspected to be related to glucagon-like peptide-1 receptor agonists (GLP-1 medicines), such as Ozempic and Mounjaro. Sometimes referred to as 'skinny jabs', they are licensed for both weight loss and Type 2 diabetes. STV News spoke to a GP earlier this year who said the weight loss drugs are the most 'transformational' she has seen in her 20-plus-year career. The drugs have been helping thousands of people at risk of poor health due to obesity to lose huge amounts of weight rapidly. Many are also prescribed weight-loss drugs privately. Common side effects such as nausea and headaches are well documented, and users are provided with guidance about what to do if they experience them. But dramatic weight loss can also result in sagging or loose skin. Those who want the excess skin to be removed can face issues. In response, the Medicines and Healthcare products Regulatory Agency (MHRA) and Genomics England will begin an investigation into acute pancreatitis through its Yellow Card Biobank. Healthcare professionals are also being asked to help recruit for the study by reporting Yellow Cards on behalf of patients experiencing acute pancreatitis while taking the medicines. Acute pancreatitis is an inflammation of the pancreas and can be 'serious' for some patients. The pancreas is a small organ, located behind the stomach, that helps with digestion. The main symptom of the condition is severe pain in the stomach that radiates to the back and does not go away. Most people with acute pancreatitis start to feel better within about a week and have no further problems. But some people with severe acute pancreatitis can go on to develop serious complications. It is different to chronic pancreatitis, where the pancreas has become permanently damaged from inflammation over many years. The most common symptoms of acute pancreatitis include: suddenly getting severe pain in the centre of your abdomen, feeling or being sick, and a high temperature of 38C or more, like a fever. Treatment for acute pancreatitis aims to help control the condition and manage symptoms. This usually involves admission to hospital. Patients may be given fluids directly into a vein (intravenous fluids), pain relief, liquid food through a tube in your tummy, and oxygen through tubes in your nose. Recent estimates suggest that about 1.5 million people in the UK are taking weight loss jabs. Health officials have suggested that they can help to turn the tide on obesity, but have stressed they are not a silver bullet and do come with side effects. Since the drugs were licensed, there have been hundreds of cases of acute and chronic pancreatitis among people taking GLP-1 medicines. 181 cases were reported of acute and chronic pancreatitis linked to tirzepatide – the active ingredient for Mounjaro. Five people died. There were 116 reported reactions of this kind linked to liraglutide, one of which was fatal. 113 cases of acute and chronic pancreatitis linked to semaglutide – the active ingredient for Ozempic and Wegovy were reported. One person died. 101 reported reactions of this kind were linked to exenatide, and three people died. There were 52 reported reactions of this sort linked to dulaglutide and 11 reported reactions linked to liraglutide. No fatalities were linked to either drug. These cases are not confirmed as being caused by the medicines, but the person who reported them suspected they may be. Dr Alison Cave, MHRA chief safety officer said: 'Evidence shows that almost a third of side effects to medicines could be prevented with the introduction of genetic testing. It is predicted that adverse drug reactions cost the NHS more than £2.2bn a year in hospital stays alone. 'Information from the Yellow Card Biobank will help us to better predict those most at risk of adverse reactions – enabling patients across the UK to receive the safest medicine for them, based on their genetic makeup. 'To help us help you, we're asking anyone who has been hospitalised with acute pancreatitis while taking a GLP-1 medicine to report this to us via our Yellow Card scheme. 'Even if you don't meet the criteria for this phase of the biobank study, information about your reaction to a medication is always extremely valuable in helping to improve patient safety.' Professor Matt Brown, Chief Scientific Officer of Genomics England, said: 'GLP-1 medicines like Ozempic and Wegovy have been making headlines, but like all medicines, there can be a risk of serious side effects. 'We believe there is real potential to minimise these, with many adverse reactions having a genetic cause. 'This next step in our partnership with the MHRA will generate data and evidence for safer and more effective treatment through more personalised approaches to prescription, supporting a shift towards an increasingly prevention-focused healthcare system. 'Although infrequent, acute pancreatitis has been reported with GLP-1 medicines. This can be serious. The main symptom of this is severe pain in the stomach that radiates to the back and does not go away. Anyone who experiences this should seek immediate medical help.' When a Yellow Card report is received, the MHRA contacts patients to ask if they would be willing to participate in the study. Patients will be asked to submit more information and a saliva sample, which will be assessed to explore whether some people are at a higher risk of acute pancreatitis when taking these medicines due to their genes. Get all the latest news from around the country Follow STV News Scan the QR code on your mobile device for all the latest news from around the country
