Latest news with #healthregulators
Yahoo
5 days ago
- Health
- Yahoo
FDA flags problems with two Boston Scientific heart devices tied to injuries and deaths
WASHINGTON (AP) — U.S. health regulators are warning doctors and patients about safety issues with two separate Boston Scientific heart devices recently linked to injuries and deaths. The Food and Drug Administration issued two alerts Wednesday about electrical problems tied to the company's heart-zapping defibrillator systems and a separate issue with a heart implant used to reduce stroke risk. The agency said the company's Endotak Reliance defibrillator wires can become calcified, leading to failures in delivering life-saving shocks to the heart, according to the FDA. Defibrillators are surgically placed in the upper chest, where they monitor irregular heartbeats and use electrical shocks to jolt the heart back to normal. As of July 24, Boston Scientific has reported 386 serious injuries and 16 deaths associated with this issue, the agency said. Ten of the deaths were judged to be due to the device failing to function properly, the company said in an email. Four were linked to attempts to surgically remove the devices from patients and two others were deemed unrelated to the implants. Boston Scientific's wires were distributed between 2002 and 2021 and are no longer available, the company noted in its letter to doctors. Some patients will need to have the devices replaced, though physicians should weigh the risks of the removal procedure. In a separate notice, the FDA said Boston Scientific recently updated instructions for implanting its Watchman device, which closes a portion of the heart's left atrium to reduce the risk of stroke. In a letter to physicians, the company noted that there is an increased risk of blockages in the bloodstream depending on the level of anesthesia for patients undergoing the initial implantation procedure. Watchman is an alternative to long-term treatment with blood thinners for patients at increased risk of stroke. As of July 30, the company has reported 120 serious injuries and 17 deaths related to the issue, the FDA said. A company investigation concluded that the safety issue 'is not associated with the design or manufacture of any component of the Watchman system. Heart devices, including defibrillators and other implants, are Boston Scientific's largest business, making up two-thirds of its $5 billion in revenue for the most recent quarter. Shares of Boston Scientific Corp. fell nearly 1.8 percent Wednesday to close at $102.95 in trading. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Yahoo
5 days ago
- Health
- Yahoo
FDA flags problems with two Boston Scientific heart devices tied to injuries and deaths
WASHINGTON (AP) — U.S. health regulators are warning doctors and patients about safety issues with two separate Boston Scientific heart devices recently linked to injuries and deaths. The Food and Drug Administration issued two alerts Wednesday about electrical problems tied to the company's heart-zapping defibrillator systems and a separate issue with a heart implant used to reduce stroke risk. The agency said the company's Endotak Reliance defibrillator wires can become calcified, leading to failures in delivering life-saving shocks to the heart, according to the FDA. Defibrillators are surgically placed in the upper chest, where they monitor irregular heartbeats and use electrical shocks to jolt the heart back to normal. As of July 24, Boston Scientific has reported 386 serious injuries and 16 deaths associated with this issue, the agency said. Ten of the deaths were judged to be due to the device failing to function properly, the company said in an email. Four were linked to attempts to surgically remove the devices from patients and two others were deemed unrelated to the implants. Boston Scientific's wires were distributed between 2002 and 2021 and are no longer available, the company noted in its letter to doctors. Some patients will need to have the devices replaced, though physicians should weigh the risks of the removal procedure. In a separate notice, the FDA said Boston Scientific recently updated instructions for implanting its Watchman device, which closes a portion of the heart's left atrium to reduce the risk of stroke. In a letter to physicians, the company noted that there is an increased risk of blockages in the bloodstream depending on the level of anesthesia for patients undergoing the initial implantation procedure. Watchman is an alternative to long-term treatment with blood thinners for patients at increased risk of stroke. As of July 30, the company has reported 120 serious injuries and 17 deaths related to the issue, the FDA said. A company investigation concluded that the safety issue 'is not associated with the design or manufacture of any component of the Watchman system. Heart devices, including defibrillators and other implants, are Boston Scientific's largest business, making up two-thirds of its $5 billion in revenue for the most recent quarter. Shares of Boston Scientific Corp. fell nearly 1.8 percent Wednesday to close at $102.95 in trading. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Associated Press
5 days ago
- Health
- Associated Press
FDA flags problems with two Boston Scientific heart devices tied to injuries and deaths
WASHINGTON (AP) — U.S. health regulators are warning doctors and patients about safety issues with two separate Boston Scientific heart devices recently linked to injuries and deaths. The Food and Drug Administration issued two alerts Wednesday about electrical problems tied to the company's heart-zapping defibrillator systems and a separate issue with a heart implant used to reduce stroke risk. The agency said the company's Endotak Reliance defibrillator wires can become calcified, leading to failures in delivering life-saving shocks to the heart, according to the FDA. Defibrillators are surgically placed in the upper chest, where they monitor irregular heartbeats and use electrical shocks to jolt the heart back to normal. As of July 24, Boston Scientific has reported 386 serious injuries and 16 deaths associated with this issue, the agency said. Ten of the deaths were judged to be due to the device failing to function properly, the company said in an email. Four were linked to attempts to surgically remove the devices from patients and two others were deemed unrelated to the implants. Boston Scientific's wires were distributed between 2002 and 2021 and are no longer available, the company noted in its letter to doctors. Some patients will need to have the devices replaced, though physicians should weigh the risks of the removal procedure. In a separate notice, the FDA said Boston Scientific recently updated instructions for implanting its Watchman device, which closes a portion of the heart's left atrium to reduce the risk of stroke. In a letter to physicians, the company noted that there is an increased risk of blockages in the bloodstream depending on the level of anesthesia for patients undergoing the initial implantation procedure. Watchman is an alternative to long-term treatment with blood thinners for patients at increased risk of stroke. As of July 30, the company has reported 120 serious injuries and 17 deaths related to the issue, the FDA said. A company investigation concluded that the safety issue 'is not associated with the design or manufacture of any component of the Watchman system. Heart devices, including defibrillators and other implants, are Boston Scientific's largest business, making up two-thirds of its $5 billion in revenue for the most recent quarter. Shares of Boston Scientific Corp. fell nearly 1.8 percent Wednesday to close at $102.95 in trading. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Yahoo
5 days ago
- Health
- Yahoo
FDA flags problems with two Boston Scientific heart devices tied to injuries and deaths
WASHINGTON (AP) — U.S. health regulators are warning doctors and patients about safety issues with two separate Boston Scientific heart devices recently linked to injuries and deaths. The Food and Drug Administration issued two alerts Wednesday about electrical problems tied to the company's heart-zapping defibrillator systems and a separate issue with a heart implant used to reduce stroke risk. The agency said the company's Endotak Reliance defibrillator wires can become calcified, leading to failures in delivering life-saving shocks to the heart, according to the FDA. Defibrillators are surgically placed in the upper chest, where they monitor irregular heartbeats and use electrical shocks to jolt the heart back to normal. As of July 24, Boston Scientific has reported 386 serious injuries and 16 deaths associated with this issue, the agency said. Ten of the deaths were judged to be due to the device failing to function properly, the company said in an email. Four were linked to attempts to surgically remove the devices from patients and two others were deemed unrelated to the implants. Boston Scientific's wires were distributed between 2002 and 2021 and are no longer available, the company noted in its letter to doctors. Some patients will need to have the devices replaced, though physicians should weigh the risks of the removal procedure. In a separate notice, the FDA said Boston Scientific recently updated instructions for implanting its Watchman device, which closes a portion of the heart's left atrium to reduce the risk of stroke. In a letter to physicians, the company noted that there is an increased risk of blockages in the bloodstream depending on the level of anesthesia for patients undergoing the initial implantation procedure. Watchman is an alternative to long-term treatment with blood thinners for patients at increased risk of stroke. As of July 30, the company has reported 120 serious injuries and 17 deaths related to the issue, the FDA said. A company investigation concluded that the safety issue 'is not associated with the design or manufacture of any component of the Watchman system. Heart devices, including defibrillators and other implants, are Boston Scientific's largest business, making up two-thirds of its $5 billion in revenue for the most recent quarter. Shares of Boston Scientific Corp. fell nearly 1.8 percent Wednesday to close at $102.95 in trading. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. Matthew Perrone, The Associated Press Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
04-07-2025
- Health
- Yahoo
New Weight-Loss Drugs Under Scrutiny Amid Pancreas Concerns
Popular weight-loss drugs like Ozempic and Zepbound have revolutionized how we tackle obesity. But now, emerging reports about potential side effects have prompted a new investigation by UK health regulators. Hundreds of people reported experiencing severe pancreas problems after taking these drugs, according to the BBC. The UK government is now asking anyone who's been affected to contact them. They are particularly interested in understanding whether genetic factors may predispose certain individuals to such severe reactions. As always with health alerts, it's crucial to put this news into perspective. There's no clear evidence yet that these drugs are directly causing pancreas damage. Their known side effects are already well-documented and they remain approved as safe for use when prescribed and overseen by a doctor. Related: And that last part – doctor oversight – is vital: it's not safe to obtain these drugs through unofficial channels. Even if you can be sure you're getting what you asked for – which you can't – these medications aren't right for everyone. It's important to note that when any medication is taken up by a large number of people, it will inevitably reach some who will experience health issues regardless of the drugs they're on, and rare adverse reactions will likely also occur. But the sheer number of reports of acute or chronic pancreatitis warrants further examination, and the cases so far involve up to 10 fatalities. The investigation is being managed by the Medicines and Healthcare products Regulatory Agency and Genomics England. Collectively, the drugs being looked at are known as GPL-1 (glucagon-like peptide-1) receptor agonists, because they target cells in the body usually activated by the natural GLP-1 hormone, which controls blood sugar and appetite – hence why they're used for diabetes and weight loss. These medications can be split into two types: those based on semaglutide (such as Ozempic and Wegovy), and those based on tirzepatide (including Mounjaro and Zepbound). The latter type also targets glucose-dependent insulinotropic polypeptide (GIP) receptors, as well as GLP-1 receptors, for a stronger effect. To date, almost 400 reports of acute pancreatitis have been received from people using GLP-1 drugs such as Mounjaro, Wegovy, Ozempic, and liraglutide, as per The Guardian. Nearly half of those, 181, involve the tirzepatide-based drug sold as Mounjaro. Genetic risk is one of the factors being studied, which may mean some people are more prone to pancreatic issues. In the case of acute or chronic pancreatitis, this manifests itself as severe stomach pain that won't go away. Those in the UK aged over 18, who have a strong adverse reaction to one of these weight loss and diabetes drugs are being asked to register their details on the Yellow Card website (the official UK system for reporting issues with approved medications). From there, you'll be asked to submit more information and a saliva sample, if you're chosen to take part in a study of GLP-1 drugs and pancreatic issues. The effects of all medications have to be considered in relation to other factors, including existing health conditions, genetics, age, and sex. Even the most effective drugs can come with risks. "GLP-1 medicines like Ozempic and Wegovy have been making headlines, but like all medicines there can be a risk of serious side effects," says geneticist Matt Brown from Genomics England. "We believe there is real potential to minimize these, with many adverse reactions having a genetic cause." Common Motion Sickness Drug Being Used to Turn People Into Zombies Your Food Packaging Is Shedding Microplastics Into Every Meal, Study Reveals Your Brain on Speed: Is Watching Video in Fast-Forward Bad For Your Memory?
