Latest news with #MedicinesandHealthcareProductsRegulatoryAgency
STV News
08-07-2025
- Health
- STV News
Mesh victims ‘still fighting for justice' five years on from review
Women harmed by vaginal mesh are 'still fighting for justice', campaigners have said on the fifth anniversary of a review into the scandal. Sling the Mesh, a campaign group representing women harmed by mesh, accused governments of 'dragging their feet' on implementing all the recommendations set out in the report. The review examined how the health service responded to concerns over pelvic mesh – which has been linked to crippling, life-changing complications including chronic pain, infections and loss of sex life; the anti-epilepsy drug sodium valproate – which has been linked to physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy, and hormone pregnancy tests such as Primodos – which are thought to be associated with birth defects and miscarriages. It concluded that patients came to 'avoidable harm' because the healthcare system failed to respond in a speedy and appropriate way when serious concerns were raised about some medical treatments. The First Do No Harm review, published in 2020, found patients were 'dismissed' and 'overlooked', while the healthcare system had a 'glacial' and 'defensive' response to concerns over treatments. It set out a series of recommendations, but campaigners have said that to date, some three of the nine recommendations set out in the review have been implemented. Sling the Mesh said that the Government had not done a retrospective audit to gauge the scale of the harm caused by mesh implants or provided compensation for women injured as a result. It also said that ministers had not delivered on a recommendation to reform the Medicines and Healthcare Products Regulatory Agency (MHRA).f Kath Sansom, founder of the Sling The Mesh campaign, said: 'It's not good enough. Five years ago, Baroness Cumberlege laid bare the systemic failures that caused irreparable harm to women across the UK. 'Yet here we are in 2025, and the Government has dragged its feet on the most critical reforms. 'Women are without compensation and still being failed by a healthcare system that was supposed to protect them.' MP Sharon Hodgson, chairwoman of the All-Party Parliamentary Group for First Do No Harm, said: 'To have this little progress five years on from the publication of the report is hugely disappointing. 'Five years ago today, things felt hopeful. The review marked what we thought would be the beginning of real systematic change, the start of building a system that listens to women when they report harm – an end to defensiveness and denial. 'Yet progress can only be seen in three out of the nine changes she proposed, with one still ongoing – leaving five completely untouched. 'Crucially, thousands of women and families who were irreversibly harmed through no fault of their own are yet to see compensation. 'Money will not make up for all they have endured. However, it would at the least remove the financial burden placed on their lives – helping them to navigate the physical, mental and financial impact these scandals have placed upon them and their families. 'Five years on, the time for excuses is over. We need action now and I call on my Government to implement all the recommendations, including updating the House on a timeline for compensation as soon as possible.' Rebekah Smith, Epilepsy Action's chief executive, said: 'It is a scandal that as far back as 35 years, thousands of women with epilepsy weren't being told about the risks involved with taking valproate in pregnancy when evidence was mounting. These women have had to live with the reality of that for decades and the huge emotional and financial impact it has on their lives. 'It is also a scandal that two reports in the last five years have recommended that families be compensated for the ordeal and yet those affected are still waiting for the light at the end of the tunnel.' Nicola Swanborough, head of external affairs at the Epilepsy Society, said: 'Five years after the publication of the Cumberlege Review, we welcome the fact that regulations have been tightened around the prescribing of valproate for women with epilepsy, reducing the risk of harm for the next generation. 'But for the families whose lives have been devastated by the side effects of valproate, there has still been no promise of the compensation that they have long campaigned for, and which was recommended by the Patient Safety Commissioner.' One of the key recommendations of the report was the appointment of a Patient Safety Commissioner, who would be an 'independent public leader with a statutory responsibility'. A commissioner was appointed, but following the Government's 10-year plan for health last week, it has been confirmed that this role will be transferred into the MHRA. Ms Sansom said: 'Moving the Patient Safety Commissioner role to the MHRA silences the patient voice instead of strengthening it. 'It strips away independence, undermines trust, and betrays the very women this role was created to protect.' Earlier this month, Health Secretary Wes Streeting said that patients do not need 'ventriloquists' from arm's length bodies to speak for them, and more weight should be given to the likes of MPs and councillors. Streeting suggested the patient safety landscape is 'cluttered', with NHS leaders receiving 'competing and contradictory instructions' from different organisations. A Department of Health and Social Care spokesperson said: 'The harm caused by pelvic mesh continues to be felt today. Our sympathies are with those affected and we are fully focused on how best to support patients and prevent future harm. 'This is a complex area of work and the Government is carefully considering the Patient Safety Commissioner's recommendations in full. 'Health Minister Baroness Gillian Merron met patients affected and has committed to providing a further update.' 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
New York Post
07-06-2025
- Health
- New York Post
Weight loss drugs like Ozempic could mess with your birth control — and get you pregnant
A UK watchdog is urging women on GLP-1 weight-loss drugs like Ozempic and Mounjaro to use effective forms of birth control after receiving more than 40 pregnancy-related reports linked to the medications. The warning comes as women flood social media with stories of their so-called 'Ozempic babies' — including surprise pregnancies while on the pill. Trying to shed pounds, not grow a baby bump? Here's what you need to know about GLP-1s, pregnancy and the best contraception options to stay protected. 4 Studies show that at least one in eight US adults have tried GLP-1s. íÅí°íâ¬í¸í½í° íâíµí¼íµíËí°í¾ – What's in your GLP-1? Several GLP-1 drugs dominate the market, including Ozempic and Wegovy. Both contain semaglutide, an active ingredient that mimics a natural hormone in the body that boosts insulin production, slows digestion and curbs appetite. Then there's Saxenda and Victoza, powered by liraglutide, which functions in a similar way. Newer drugs like Mounjaro and Zepbound rely on tirzepatide, a key ingredient that targets a second hormone involved in appetite and blood sugar control. A surprise side effect While gastrointestinal symptoms like nausea, vomiting and diarrhea are common with GLP-1s, the surprise side effect making waves is unexpected pregnancy. The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has received 28 reports related to pregnancy in patients on tirzepatide, and nine each for semaglutide and liraglutide. 4 Women on tirzepatide-based GLP-1s should use barrier contraception. nenetus – In an alert this week, the agency warned that tirzepatide may reduce the effectiveness of oral contraceptives, especially in women with higher body weight. As a result, it recommended using barrier methods like condoms while on drugs like Mounjaro. So far, there's no evidence that GLP-1s affect non-oral birth control like IUDs, implants, patches, or rings, according to the UK's Faculty of Reproductive Healthcare. And yes, the advice applies even to women previously told they were infertile. GLP-1s have been shown to boost fertility by aiding weight loss, reducing inflammation and improving insulin sensitivity — leading some to conceive just months after starting treatment. 4 GLP-1 agonists can increase your fertility, but they can also interfere with pregnancy. Louis-Photo – Can you take GLP-1s while pregnant? Experts say no — at least not yet. There's not enough data to confirm whether GLP-1s are safe during pregnancy. While a some human studies suggests there is no harm in first-trimester use, testing in animals has shown the drugs could increase the risk of miscarriage and birth defects. 4 Scientists are still working to understand whether GLP-1s can negatively impact a developing fetus. Evrymmnt – Another reason to skip GLP-1s while pregnant: they suppress your appetite and can trigger gastrointestinal issues, which may lead to nutrient deficiencies that impact fetal development. The drugs should also be avoided during breastfeeding, since there's not enough research to confirm safety for infants. Trying to conceive? Here's the timeline If you're planning to get pregnant, the MHRA recommended stopping GLP-1s before you start trying to conceive and giving your body time to clear the drugs. For semaglutide users, that means quitting at least two months ahead. If you're on tirzepatide, stop one month before trying. Liraglutide clears the system faster, so you can stop right before you start trying to conceive.
Daily Record
05-06-2025
- Health
- Daily Record
Urgent contraception warning issued to 'skinny jab' users for one key reason
Weight-loss injections have become incredibly popular in the past year - but the government has warned that they can interact with contraception in new guidelines The government has issued a warning for women taking weight-loss injections and urged them to use effective contraception. A new notice from the Medicines and Healthcare Products Regulatory Agency said that one type of injection, Mounjaro, may reduce the effectiveness of oral contraceptives (the pill) in those who are overweight. Therefore, anyone taking Mounjaro who could get pregnant, should also use a non-oral form of contraception such as the implant, coil, or condoms. This is especially important for the four weeks after starting the injections and after any dose increase. The official government advice says: "Mounjaro may reduce the effectiveness of oral contraceptives in those who are overweight. Therefore, those taking Mounjaro who are overweight and are using an oral form of contraception are advised to also use a non-oral form of contraception. "This only applies to those taking Mounjaro and is especially important for the four weeks after starting Mounjaro and after any dose increase." Weight-loss drugs must also not be taken during pregnancy, while trying to get pregnant, or during breastfeeding. If you get pregnant while on the injections, you should speak with your healthcare provider and stop the medicine as soon as possible, the government advised. It explained: 'This is because there is not enough safety data to know whether taking the medicine could cause harm to the baby.' Dr Alison Cave, MHRA chief safety officer, said: 'Skinny jabs are medicines licensed to treat specific medical conditions and should not be used as aesthetic or cosmetic treatments. They are not a quick fix to lose weight and have not been assessed to be safe when used in this way.' The new guidance also reminded patients that weight-loss medications should not be bought from unregulated sellers such as beauty salons or via social media. This exposes people wanting to lose weight to 'serious health risks' and is against the law. Legitimate medicines will be provided in pre-filled injection pens - meaning that products supplied as a powder in vials that need to be mixed with a liquid before injection are not authorised. There have also been reports of fake pre-filled pens that appear similar to the licensed medication. The MHRA warned that while these may look genuine, they 'can also be dangerous', adding: 'The only way to guarantee you receive a genuine GLP-1 medicine is to obtain it from a legitimate pharmacy, including those trading online, with a prescription issued by a healthcare professional.' The guidelines also highlighted the importance of being able to recognise symptoms of acute pancreatitis - an uncommon complication that can develop. If you are on weight-loss injections and suddenly get severe pain in your abdomen and feel sick, you should seek immediate help. Dr Cave said: 'This guidance should not be used as a substitute to reading the patient information leaflet or having a conversation with a healthcare professional as part of the prescribing process.' If you are taking a GLP-1 medicine and are set to undergo a surgical procedure, you should inform your healthcare team. This is because the medicine slows the emptying of your stomach, which increases the risk that stomach contents could enter into your airway and lungs during surgery.
Channel 4
28-05-2025
- Health
- Channel 4
‘Time is muscle' – children trapped in postcode lottery for life-extending drug
In the Duchenne community they say time is muscle. So the clock is always ticking for the loved ones of those suffering with this form of muscular dystrophy . Six months ago those families were given hope – only for it to be dashed. Duchenne causes progressive muscle degeneration and weakness. Becoming non-ambulatory – not being able to walk – can happen anytime between the ages of 8 and 12. People with Duchenne live into their twenties and thirties on average, but access to better treatments and care can help extend their lives. And in December, there was potential good news when the Medicines and Healthcare Products Regulatory Agency (the MHRA) approved a new drug. Givinostat is the first drug to show a slowing down of that degeneration – to give boys – and it is mainly boys affected – longer literally on their feet. And the drug company that makes it said it would provide it to patients free. But Channel 4 News has found that across England though hospitals are either delaying or are refusing to give the new treatment. This has become a postcode lottery. Great Ormond Street Hospital (GOSH) has said it will begin to treat Duchenne boys next week with the drug, but said its introduction has been challenging at a time when resources across the whole NHS are more stretched than ever, and they are working hard to identify the funding required. In South London, at the Evelina children's hospital, they have told parents treatment will begin in late summer. Meanwhile other centres have not even gone that far – and patients are left waiting to see if they will get the drug at all. We spoke to Alex Clarke, whose son Ben has Duchenne. Their local trust, Oxford University Hospitals, has told families that despite the drug itself being provided free, they cannot afford to use it to treat their patients. Channel 4 News has now seen internal emails from the Oxford Trust, discussing the potential costs of introducing the drug. Professor Andrew Brent, the trust's medical officer, writes: 'Unfortunately, however, given the current financial climate and the expectation … to make significant savings, we are not in a position to fund services/treatments that are not nationally approved without stopping doing something else.' The trust's chief finance officer responded, stating: 'It is not our job to fund new medicines that are not NICE approved.' Later in a statement Professor Brent said: 'It is a measure of the importance we place on Givinostat that we have been working on a business case before the drug has been approved by NICE. We will continue working towards being able to offer the treatment once approved by NICE, as we hope it will be.' That business plan seen by Channel 4 News said it will cost just over £66,000 for about 35-40 patients. While waiting for evaluation, and hopefully approval, from the National institute for Health and Care Excellence (NICE), patients can be treated under the early access programme. This was set up at the same time as the MHRA approval but it took until March this year for the first trust to agree – that was the Leicester Royal Infirmary, followed by Cardiff and Swansea. Under the early access programme trusts have to pay out of their own budget for the administration and monitoring of the drug. In March, parents met with the Health Secretary Wes Streeting but today the Department of Health and Social Care said: 'We are aware of the immense challenges faced by people living with rare diseases such as Duchenne's muscular dystrophy, and their families. 'The department is committed to supporting access to specialist care, treatment and drugs for those with these conditions.' It would appear their hands are tied. Progressive MS patients given new hope in world first drug trial Batten disease: Fears drug treatment may be withdrawn New HIV drug 100% effective – but why does it cost $40,000?
ITV News
23-05-2025
- Health
- ITV News
How skinny jabs could invalidate your holiday insurance
An explosion in the skinny jab black market has led to warnings about their safety, the risk of counterfeits, and how taking prescription medication without it being signed off by a doctor can have unintended consequences. One area this could catch people out is how taking these drugs abroad could impact someone's travel insurance. Stories of people having their insurance suddenly revoked once their provider had found out they were taking one of the jabs have been popping up in forum posts across the internet. Drugs like Wegovy and Mounjaro are prescribed on the NHS for people with obesity, but interest among healthy people about their potential weight-loss benefits has led to a surge in demand for them. They can not be legally purchased without a doctor recommending them to a patient, but this has not stopped a booming marketplace for them from appearing on the internet. Recently, ITV News was able to purchase skinny jab pens via an Instagram account, which had posted some of the videos, and tests later revealed the substance was unfit for human use. Numerous health bodies have warned against them being taken for "aesthetic" reasons. The Medicines and Healthcare Products Regulatory Agency said last year, the "benefits and risks of using these medicines for weight loss by individuals who do not have obesity or who are not overweight with weight-related comorbidities have not been studied." With most of these drugs requiring a once-weekly injection, many people who choose to take them may assume they can easily take them abroad so they do not miss a dose while on holiday. But this is not the case, Ozempic, Mounjaro or any of the other weight loss jabs are serious medications, and they should not be treated like paracetamol or something you can just buy over the counter. The Association of British Travel Agents told ITV News it is always advisable to check with the FCDO travel advice to see if there are any restrictions in place when taking medications into the country you are visiting. Not every country in the world has approved the same weight-loss drugs as the UK has, and airport officials may have questions about any medication they find, especially if it is not approved in their country. What happens if you don't inform your provider that you take one of the jabs? There are two key answers here, and it depends on whether the drug is being taken as part of a preexisting condition or if it is being taken for personal reasons only and has not been prescribed by a doctor. First of all, you need to declare a pre-existing condition to your travel insurance provider anyway. This will likely result in a higher premium, but if you do not and the provider finds out, they may cancel your cover. They will also likely refuse to pay out if you fall ill due to the condition while on holiday. If one of the jabs has been prescribed for the preexisting condition they it is unlikely you will need to also reveal the medication you are taking for it. Where it is less clear cut is if the drug is being taken and it has not been prescribed. If the drug causes side effects to the user without it being prescribed, and medical attention is needed, then an insurance provider may refuse to pay to cover the cost. They could go as far as cancelling the insurance altogether, but this will vary from provider to provider. What have travel provider insurers said? ITV News asked several major travel insurance providers what their stances were on customers taking Ozempic, Wegovy or Mounjaro, and they warned against keeping it secret, but had different views on whether it would outright invalidate any cover they provide. Admiral told ITV News that not declaring the medication itself won't invalidate the insurance, but failing to disclose the underlying condition it is prescribed for would. They said if someone was taking it without GP advice, "not disclosing it to your travel insurer could impact your cover if side effects lead to a claim." Alan Dean, Managing Director of travel insurer, CoverForYou, told ITV News: "Taking prescription medication without a prescription is both illegal and potentially dangerous, therefore, taking any prescribed medication without a prescription would also invalidate your insurance. "To be really clear, any claim directly or indirectly caused by you taking prescribed medication without a prescription would be invalid. "It's also worth noting, if you're taking prescription medication out of the UK, you should check the rules of the country you're going to. "You may need to prove it's yours with either a prescription or letter from your doctor." Aviva said: "Our policies require customers to inform us of any diagnosed illness, disease, or injury for which they have been prescribed medication; received or are awaiting tests/investigations; been under or are still under a specialist, or have been admitted to hospital or had surgery. "This includes anyone who has been prescribed weight loss medication - such as Ozempic or Mounjaro - for obesity. If a customer fails to disclose a medical condition - such as obesity - for which they've been prescribed medication, we will not cover any claims relating to this under the terms of the policy."
