The US Food and Drug Administration is advising extra precautions after seizing thousands of units of counterfeit Ozempic, according to a notice issued Thursday.
Imitation drugs have been linked to five cases of illness so far, the agency said, but none have been reported as serious. Those who used the fake doses reported adverse reactions consistent with the real product, including nausea, vomiting, diarrhea, abdominal pain and constipation.
While the FDA and Ozempic’s manufacturer, Novo Nordisk, have already collected and tested thousands of samples, they warn that some counterfeit products can still be purchased.
Consequently, wholesalers, retail pharmacies, health care practitioners and patients are advised to check any semaglutide they have received to ensure they are not part of the bogus supply, which is labeled with lot number NAR0074 and serial number 430834149057.
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Watch out for fakes
The FDA and Novo Nordisk are currently analyzing the collected samples to determine their content, safety and effectiveness. So far, they have determined that the products’ pen labels, healthcare professional and patient information and the carton the medicine comes in are all fake.
Importantly, the needles were also found to be counterfeit, meaning their sterility could not be confirmed and could pose a higher risk of infection to patients.
Anyone currently in possession of a semaglutide product is advised to inspect it carefully before using, selling or otherwise distributing it to confirm not only the lot and serial number, but also its labeling and packaging. The FDA encourages consumers to compare the photos posted on their website of the actual Ozempic packaging to the products in their supply for differences in color, labels and overall appearance.
The agency also reminded pharmacies to buy Ozempic only through authorized Novo Nordisk distributors and patients only to obtain it by prescription from a state-licensed pharmacy. All those handling the product are advised to inspect it carefully for signs of tampering or counterfeiting.
What is Ozempic (semaglutide)?
What is Ozempic:You’ve heard of Ozempic, but do you understand how it works?
Weight loss drugs have become one of the hottest health topics in 2023. Originally intended to manage diabetes, the most popular drug, semaglutide, has gained immense popularity for its ability to promote rapid weight loss among patient.
Semaglutide is the generic name for Wegovy, which is approved for weight loss, and Ozempic, which is used to treat diabetes. Both are made by Novo Nordisk.
Ozempic works by mimicking the hormone GLP-1, which helps the pancreas release insulin. It promotes weight loss by sending signals to the appetite center in your brain to reduce hunger and increase satiety, making it easier to manage hunger cues, stick to smaller and smaller meals and overcome cravings. emotional or boredom eating.
Semaglutide has been shown to help patients lose 15% to 20% of their body weight but it is also expensive and often not covered by insurance if used primarily for weight loss.
Costing about $1,000 a month for weekly injections, the drugs have also been shown to present some serious drawbacks, one of which is a tendency for consumers to regain the weight after stopping treatment. There is also a low risk of pancreatitis, gallstone disease and gastroparesis.
Semaglutide has been in short supply for nearly two years, largely because it is increasingly prescribed off-label to people without diabetes.
While Ozempic was approved for the treatment of diabetes in 2017, Wegovy was only approved for use in weight loss in 2021, causing an explosion in demand.
As USA TODAY previously reported, Novo Nordisk has struggled to keep up with high demand, as data released in September showed that prescriptions increased in major metropolitan areas within the first year of Wegovy’s approval. In some locations, such as Cleveland and Seattle, prescriptions for semaglutide increased by 481% and 351%, respectively.
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