Latest news with #MHRA
The Sun
an hour ago
- Health
- The Sun
Warning to Brits getting common jab over ‘small risk' of paralysing illness
OVER 20 people developed a potentially paralysing illness after getting the respiratory syncytial virus (RSV) vaccine. The UK's medicines watchdog says the jab comes with a "small risk" of Guillain-Barré syndrome, a nerve disorder that can cause muscle weakness, numbness and, in severe cases, paralysis. 1 But despite the warning, officials say the benefits of the potentially lifesaving vaccine still outweigh the risks. The Medicines and Healthcare products Regulatory Agency (MHRA) has urged NHS staff after reports linked the condition to Pfizer's Abrysvo and GSK's Arexvy vaccines. The jabs are offered to older adults and pregnant women to protect against RSV - a cold-like illness that can make some people seriously ill. Every year, around 30,000 children and 24000 adults in the UK end up in hospital with severe breathing problems caused by the virus, including pneumonia and bronchiolitis, a dangerous airway infection. And each winter, about 100 children die from RSV. It's also linked to around 8,000 adult deaths, as the infection puts deadly strain on the heart, leading to organ failure. Since the jab rolled out on the NHS this September for the first time, 1.3 million people aged 75 to 79 have been vaccinated. The Commission on Human Medicines still advises that "the benefits of vaccination against RSV outweigh the small risk of developing Guillain-Barre syndrome in older adults". In its alert, published today, the MHRA said: "Healthcare professionals should advise all recipients of Abrysvo and Arexvy that they should be alert to signs and symptoms of Guillain-Barre syndrome and, if they occur, to seek immediate medical attention as it requires urgent treatment in hospital." It warned staff to be alert to the signs and symptoms of the syndrome. What is RSV (Respiratory Syncytial Virus) or bronchiolitis? There is currently no evidence of increased risk for pregnant women vaccinated with Abrysvo, the only RSV jab approved for use during pregnancy, health chiefs said in the alert. The Pfizer vaccine Abrysvo is offered on the NHS to adults aged 75 to 79 and pregnant women. The GSK vaccine Arexvy is not yet available on the NHS but may be accessible privately. Symptoms of Guillain-Barre syndrome can include tingling, numbness or pins and needles in feet and hands, muscle weakness and difficulty moving joints. There may also be problems breathing and drooping face muscles or trouble swallowing or speaking. Up to June 2, the MHRA received 21 Yellow Card reports of suspected Guillain-Barré in older adults after Abrysvo, out of more than 1.9 million doses given. No cases have been linked to Arexvy in the UK so far, but this vaccine has been used very little. The Yellow Card scheme is the UK's system for collecting reports of possible side effects from medicines and vaccines, helping regulators monitor safety. In the US, studies suggest nine extra Guillain-Barré cases per million doses for Abrysvo and seven per million for Arexvy. What is Guillain-Barré syndrome? Guillain-Barré syndrome (GBS) is a rare condition that affects the nerves. About 1,500 people develop it in the UK every year, and it is more common in adults and men. It's not known exactly what causes GBS, but it's thought to be related to problems with the immune system as it usually begins with a few weeks of an infection, such as flu or a stomach bug. Normally when you get an infection, your immune system attacks and kills the bacteria or virus. But in GBS, the immune system starts to attack your nerves. This can cause symptoms, including: Tingling Numbness Pins and needles Muscle weakness Difficulty moving your joints Sharp, shooting pains Problems breathing Drooping face muscles Trouble swallowing or speaking Eyesight issues, such as double vision Some people's symptoms are so severe, they become paralysed and cannot move their legs, arms or face. GBS is serious and requires urgent treatment in hospital, sometimes for several months. Most people will be able to walk within six months and recover within a year. Source: NHS
Scottish Sun
an hour ago
- Health
- Scottish Sun
Warning to Brits getting common jab over ‘small risk' of paralysing illness
Health chiefs say there is no evidence the risk of Guillain-Barré syndrome applies to pregnant women vaccinated with the RSV jab JAB ALERT Warning to Brits getting common jab over 'small risk' of paralysing illness Click to share on X/Twitter (Opens in new window) Click to share on Facebook (Opens in new window) OVER 20 people developed a potentially paralysing illness after getting the respiratory syncytial virus (RSV) vaccine. The UK's medicines watchdog says the jab comes with a "small risk" of Guillain-Barré syndrome, a nerve disorder that can cause muscle weakness, numbness and, in severe cases, paralysis. Sign up for Scottish Sun newsletter Sign up 1 The benefits of RSV vaccination far outweigh the tiny risk of Guillain-Barré syndrome in older adults But despite the warning, officials say the benefits of the potentially lifesaving vaccine still outweigh the risks. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert to NHS staff after reports linked the condition to Pfizer's Abrysvo and GSK's Arexvy vaccines. The jabs are offered to older adults and pregnant women to protect against RSV - a cold-like illness that can make some people seriously ill. This includes pneumonia and bronchiolitis, an infection that causes swelling of the small airways in the lungs. Since the jab launched on the NHS this September, 1.3 million people aged 75 to 80 have been vaccinated. The Commission on Human Medicines still advises that "the benefits of vaccination against RSV outweigh the small risk of developing Guillain-Barre syndrome in older adults". In its alert, published today, the MHRA said: "Healthcare professionals should advise all recipients of Abrysvo and Arexvy that they should be alert to signs and symptoms of Guillain-Barre syndrome and, if they occur, to seek immediate medical attention as it requires urgent treatment in hospital." It warned staff to be alert to the signs and symptoms of the syndrome. There is currently no evidence of increased risk for pregnant women vaccinated with Abrysvo, the only RSV jab approved for use during pregnancy, health chiefs said in the alert. The Pfizer vaccine Abrysvo is offered on the NHS to adults aged 75 to 79 and pregnant women. The GSK vaccine Arexvy is not yet available on the NHS but may be accessible privately. What is RSV (Respiratory Syncytial Virus) or bronchiolitis? Symptoms of Guillain-Barre syndrome can include tingling, numbness or pins and needles in feet and hands, muscle weakness and difficulty moving joints. There may also be problems breathing and drooping face muscles or trouble swallowing or speaking. Up to June 2, the MHRA received 21 Yellow Card reports of suspected Guillain-Barré in older adults after Abrysvo, out of more than 1.9 million doses given. No cases have been linked to Arexvy in the UK so far, but this vaccine has been used very little. The Yellow Card scheme is the UK's system for collecting reports of possible side effects from medicines and vaccines, helping regulators monitor safety. In the US, studies suggest nine extra Guillain-Barré cases per million doses for Abrysvo and seven per million for Arexvy.
The Sun
2 hours ago
- Health
- The Sun
Eye drops used as hayfever remedy urgently recalled over risk of severe infection
BRITS have been warned eyedrops used as a hayfever remedy have been recalled over risk of serious infection. Retailers have been advised to "stop supplying" the affected batch "immediately". Potential side effects include a number of eye infections, including conjunctivitis, keratitis, and/or blepharitis, or, for susceptible patients, could be a more severe infection. A spokesperson from Medicines and Healthcare products Regulatory Agency said: "Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34. "Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contamination of the medicinal product. "As a precautionary measure the specific batch mentioned in this notification is being recalled. "To date, Thea Pharmaceuticals Limited have not received any reports of adverse incidents or product quality complaints related to this potential defect." The affected batch are number 4V64, with the expiry date September 30, 2026. The pack size is 5ml, and they were first distributed on January 27 this year. All stock must also be quarantined, and returned to the supplier, using the approved process. Thea Pharmaceuticals confirmed 11,360 packs of this batch were released and distributed. There have been no reported adverse events or product quality complaints received to date. And, no further action is required by patients as this is a Pharmacy and Wholesaler level recall. The spokesperson added: "Whilst the recall is precautionary and no adverse events have been reported by Thea Pharmaceuticals Limited, if any side effects were to be observed, these would be related to ocular infection and may include conjunctivitis, keratitis, and/or blepharitis, or, for susceptible patients, could be a more severe infection. "Patients who experience adverse reactions or have any questions about the medication should seek medical attention. "Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme." Your product recall rights Chief consumer reporter James Flanders reveals all you need to know. Product recalls are an important means of protecting consumers from dangerous goods. As a general rule, if a recall involves a branded product, the manufacturer would usually have lead responsibility for the recall action. But it's often left up to supermarkets to notify customers when products could put them at risk. If you are concerned about the safety of a product you own, always check the manufacturer's website to see if a safety notice has been issued. When it comes to appliances, rather than just food items, the onus is usually on you - the customer - to register the appliance with the manufacturer as if you don't there is no way of contacting you to tell you about a fault. If you become aware that an item you own has been recalled or has any safety noticed issued against it, make sure you follow the instructions given to you by the manufacturer. They should usually provide you with more information and a contact number on its safety notice. In some cases, the manufacturer might ask you to return the item for a full refund or arrange for the faulty product to be collected. You should not be charged for any recall work - such as a repair, replacement or collection of the recalled item 1 is your go-to destination for the best celebrity news, real-life stories, jaw-dropping pictures and must-see video.
Daily Mail
2 hours ago
- Health
- Daily Mail
BREAKING NEWS Urgent warning issued as drug chiefs recall common eye drops due to risk they could cause BLINDNESS
Health officials have urgently recalled over 11,000 eye drops due to manufacturing issues that may have made the products unsterile that could leave patients blind. UK medicines watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA) slapped an alert on one batch of Zaditen 0.25mg/ml eye drops, used to treat seasonal allergies such as hay fever. It is feared the drug may have been contaminated during manufacturing, causing side effects including conjunctivitis and inflammation of the cornea and eyelid. Left untreated, these conditions can cause permanent eye damage and even blindness. But the MHRA, which published the alert today, said it had not yet received any complication or reports of harm from patients who had taken the commonly-prescribed eye drops. The recall only impacts one batch of the 5ml eye drop solution, manufactured by Laboratoires Théa, with the batch number 4V64 and an expiry date of September 30 2026.
Daily Mirror
3 hours ago
- Health
- Daily Mirror
'Seek immediate treatment' alert as serious condition linked to jab
The UK's medicines regulator has warned NHS healthcare staff about an increased risk of a condition affecting the nerves in people who have been vaccinated The Medicines and Healthcare products Regulatory Agency (MHRA) has flagged an increase in risk of a rare neurological disorder following vaccination against respiratory syncytial virus (RSV). Guillain-Barre syndrome, an uncommon but serious illness, requires swift hospitalisation to halt its progress. Symptoms generally emerge first in the limbs and can impair sensation, movement, respiration and heart function. Following a connection between 21 suspected instances of Guillain-Barre syndrome in adults aged 60 or older with the Pfizer-produced Abrysvo and GSK's Arexvy vaccines, the MHRA has sent out a drug warning about the RSV inoculations. Despite this concern, the Commission on Human Medicines maintains that "the benefits of vaccination against RSV outweigh the small risk of developing Guillain-Barre syndrome in older adults". The MHRA said: "Healthcare professionals should advise all recipients of Abrysvo and Arexvy that they should be alert to signs and symptoms of Guillain-Barre syndrome and, if they occur, to seek immediate medical attention as it requires urgent treatment in hospital." The agency cautioned healthcare workers to stay vigilant for indications of the syndrome and added that, as of now, there is no perceived heightened threat of Guillain-Barre syndrome post-vaccination in expectant mothers using Abrysvo, which remains the sole permitted RSV vaccine during pregnancy. The RSV vaccine aids in safeguarding against the respiratory syncytial virus, a condition that can severely affect older adults and infants. In babies, RSV can lead to bronchiolitis, causing breathing difficulties, while in older individuals, it can result in pneumonia, both potentially necessitating hospitalisation. Currently, the NHS offers Pfizer's RSV vaccine Abrysvo to adults aged 75 to 79 and pregnant women. The GSK RSV vaccine Arexvy is not presently available on the NHS, but it may be accessible privately within the UK. Guillain-Barre syndrome symptoms can manifest as tingling sensations, numbness or pins and needles in the hands and feet, muscle weakness, and joint movement difficulties. Other symptoms might include breathing problems, sagging facial muscles, or issues with swallowing or speaking. As of June 2, the MHRA has received 21 Yellow Card reports of suspected Guillain-Barre syndrome in older adults (aged 75-79 where known) following the administration of Abrysvo. This is in the context of over 1.9 million doses of Abrysvo being administered, according to the agency. During the same period, the MHRA has not received any Yellow Card reports of suspected Guillain-Barre syndrome following the use of Arexvy, although this vaccine has seen very limited usage in the UK so far. A study conducted in the US suggested that Abrysvo and Arexvy were linked to nine and seven excess cases of Guillain-Barre syndrome per million vaccine doses administered, respectively.
