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FDA Investigates Fatalities Tied to Counterfeit Ozempic
Shortages of semaglutide and counterfeit drugs bring tremendous health concerns demanding more investigations of the FDA.
United States: The CEO of the firm that produces diabetes and obesity treatment Ozempic and Wegovy has said that copies of the active component in those products have been the cause of at least 100 cases of hospitalizations and 10 deaths, as reported by HealthDay.
“Honestly, I’m quite alarmed by what we see in the U.S. now,” Novo Nordisk President and CEO Lars Fruergaard Jorgensen told CNN on Wednesday. “Patients who believe that they’re getting access to a safe product, and they believe they’re getting semaglutide … I know for a fact that they are not getting semaglutide, because there’s only one semaglutide, and that’s produced by Novo Nordisk, and we don’t sell that to others.”
The Growing Problem of Compounded Drugs
The compounded drug refers to those drugs that are prepared by other pharmacies or manufacturers other than the firms that have the approved products, and they are usually permitted in the course of the shortage of those approved products.
Semaglutide and other GLP-1 and diabetes drugs have been in short supply in the past two years as millions of Americans sought out the drugs for substantial weight loss.
Novo Nordisk said, in the weekly update of products on shortage last week, of the semaglutide, the last one left in short supply is the least dose of Wegovy, CNN reported.
“We’re collaborating with the FDA, and I think they’re looking into some of the considerations they have to make because I think they’re equally concerned about the health of patients,” Jorgensen said. “So exactly how that will play out, I think, still remains to be seen.”
Where did the distressing figures for deaths and hospitalizations appear? These were obtained from the U.S. Food and Drug Administration adverse event reporting system for semaglutide.
However, the FDA points out that records in that database are in the form of reportage and are un-reviewed, which does not guarantee that the drugs indeed caused the reported damages. The agency has not answered a query on the reports regarding the matter.
FDA Investigation into Counterfeit Drugs
Still, the agency said in October that it had received “multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products.”
The FDA has also stated that some of the compounders may have compounds that contain a different salt form of semaglutide and that there are counterfeit forms of Ozempic.
Supply Chain Struggles and Continued Shortages
Semaglutide and another GLP-1 medicine, tirzepatide (Mounjaro/Zepbound), have been named on the list of drugs in shortage list since 2022 as more and more people are using them for health issues.
Last month, the FDA stated that there was an availability of tirzepatide, and later on, the FDA posted that the earlier information was incorrect due to litigation, as reported by HealthDay.
Meanwhile, the FDA told CNN last week that it’s “currently working to determine whether the demand or projected demand for semaglutide within the United States exceeds the available supply.”
News
Over 10 Hours Sitting? Your Heart May Suffer
Cutting excessive sitting time to under 10.6 hrs per day for an individual to keep moving can help decrease the prevalence of heart diseases and related fatalities.
United States: A new study reveals that any sedentary behavior that involves sitting, reclining, or lying down during the day can raise a person’s risk of heart disease or death.
Folks who sit for more than 10.5 hours a day, including work and leisure time, have a higher risk of heart failure and heart disease death, regardless of whether they meet guidelines for exercise, studies show, as reported by HealthDay.
“Our findings support cutting back on sedentary time to reduce cardiovascular risk, with 10.6 hours a day marking a potentially key threshold tied to higher heart failure and cardiovascular mortality,” said co-senior researcher Dr. Shaan Khurshid, a cardiologist at Massachusetts General Hospital in Boston. “Too much sitting or lying down can be harmful to heart health, even for those who are active.”
These findings are in line with another research conducted recently and published in the journal PLOS One, which revealed that as people remained inactive for more time, their hearts grew faster. This was the case regardless of how the people followed the basic guidelines of at least 30 minutes of exercise per day.
Key Findings
In the new research, participants of the UK ongoing research project called Biobank study involving nearly 90,000 people were included. The amount of time spent on sedentary behavior per day was 9.4 hours among the participants.
After an average follow-up of eight years, about 5% of the patients had developed an irregular heartbeat, 2% had developed heart failure, just under 2% had suffered a heart attack, and about 1% died of heart-related disease, the researchers discovered.
It was found that sedentary behavior gradually raised the chances of abnormal heartbeat and heart attack among individuals studied on the subject.
As the sedentary time increased, people’s risk for heart failure and heart-related death did not escalate until they sat more than 10.6 hours a day. However, after that it increased to a moderate level of risk.
Exercise Isn’t Enough
The subjects who spent more time sitting in cars, watching and at their desks were more likely to have heart failure or die from heart-related causes, even if they exercised 150 minutes a week.
“Future guidelines and public health efforts should stress the importance of cutting down on sedentary time,” Khurshid said in a news release. “Avoiding more than 10.6 hours per day may be a realistic minimal target for better heart health.”
In an accompanying editorial, Dr. Charles Eaton of Brown University in Rhode Island pointed out that people always overestimate their level of physical activity and underestimate their periods of inactivity, as reported by HealthDay.
Reducing sitting time by 30 minutes per day with any form of physical activity also decreases heart health risks, opined Eaton, who directs Center for Primary Care and Prevention at Brown.
Moderate-to-vigorous activity reduced the risk of heart failure by 15% and of fatal heart disease by 10%; light activity lowered heart failure risk by 6% and fatal heart disease risk by 9%.
News
E. Coli Outbreak from McDonald’s Onions Affects 104 People
The E. coli outbreak related to McDonalds’ slivered onions this year has been reported to have hospitalizing effect and one fatality, with the onions sourced from Taylor Farms.
United States: Victims in an E. coli outbreak linked to slivered onions that were served on McDonald’s Quarter Pounders have increased to 104, U.S health officials said Wednesday.
On its website, the U.S. Food and Drug Administration stated that 34 people have been admitted to the hospital, four of whom have severe cases of kidney damage and one fatality, as reported by HealthDay.
Colorado Among States Hit Hardest by the Outbreak
Fourteen states have been affected by the outbreak, according to the FDA: Obviously, the highest figures are reported by Colorado (30), Montana comes second (19), and Nebraska takes third place (13).
In assigning responsibility regarding the outbreak, both FDA and McDonalds have blamed slivered onions supplied by Taylor Farms, a producer of fresh fruits and vegetables based in California. Sheldon recalled the yellow onions on Oct 22.
Samples have not yet been analyzed for the onions that have already been recalled, but “at this time, there is no indication of a sustained food safety risk linked with this outbreak at outlets that are opened by Mcdonald’s,” the FDA noted in the update section.
At the same time, McDonald’s announced on Wednesday that it had returned Quarter Pounders with slivered onions to restaurants that had been impacted.
Resumes Serving Quarter Pounders with Onions
“McDonald’s identified an alternate supplier for the approximately 900 restaurants that had temporarily stopped serving Quarter Pounder burgers with slivered onions,” the company said in a statement. “Over the past week, these restaurants resumed the sale of Quarter Pounder burgers with slivered onions.”
In its statement, McDonald’s added, “Food safety is something we will never compromise on, and we remain committed to doing the right thing.”
However, it was reported by NBC News that many complaints have been registered against McDonald’s after the outbreak was declared, among which is a proposed class action lawsuit.
Symptoms and Risks of E. Coli Infections
For most of the individuals affected by the E. coli strain, a cure is not even needed since they recover on their own. Other related symptoms, apart from severe ones, are abdominal pain, stools that contain blood, and vomiting. In some of the worst cases, it may lead to high BP, kidney disease, a neurologic disorder, or even hemolytic uraemic syndrome, which causes kidney failure, the CDC says.
News
Vape Laws Fail to Stop Teens from Buying Online
Increased vigilance and severe measures are required to reduce the risks that teenagers face using selected vaping products from the internet.
United States: Strategies adopted by the federal Government to ensure that children did not access vaping products include closing shops that sell the products to under-aged people, but new research shows children can still get the products from online shops. The Preventing Online Sales of E-Cigarettes to Children Act (2020) was supposed to ban sales of e-cigarettes via the USPS and to introduce mandatory picture identification for delivery. But there is evidence of the shortcomings indicated in a study and people can easily make online purchases, as reported by HealthDay.
What the Study Found
Researchers tested the purchase of flavored nicotine vaping products from 78 online retailers, attempting to have the products delivered to their homes. The results were troubling:
- 78% of deliveries occurred without any ID check or interaction with delivery personnel.
- 16% involved interaction, but no ID verification.
- Only 5.7% had their ID checked, but it wasn’t scanned.
The study found that the U.S. Postal Service (USPS) delivered 80% of the orders, despite a federal law prohibiting the USPS from shipping tobacco products. This clear violation of the law points to gaps in enforcement and further exposes the vulnerability of online tobacco sales.
Issues with Online Age Verification
While websites use age-gating technology to prevent underage purchases, it is easily bypassed by minors who provide false information. Unlike physical stores where clerks can check IDs in person, online systems cannot verify the buyer’s identity. Thomas Carr, director of national policy for the American Lung Association, stresses the simplicity of circumventing these age checks, making it easier for minors to get their hands on e-cigarettes.
Health Risks for Teens
Nicotine in particular, in flavored products that are marketed towards young people is very toxic and addictive for teenagers. This is according to Dr. Harati who explains that nicotine damages the developing hard hence making teenagers highly susceptible to substance dependence, as reported by HealthDay.
Calls for Stronger Action
The online cigarettes sale loopholes are slammed by health organizations such as the American Academy of Pediatrics and the American Lung Association of today. Therefore, there is a need to implement additional e-cigarette delivery restraints and the prohibition of more flavors. It has been found that making the products less appealing and harder to access can contribute to the safeguarding of youths from the risks of vaping.
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