The U.S. Food and Drug Administration is advising extra caution after seizing thousands of units of counterfeit Ozempic products, according to a statement released Thursday.
According to the agency, imitation drugs have been linked to five cases of illness, but none have been reported as serious. Those who used counterfeit doses have reported side effects consistent with the original product, including nausea, vomiting, diarrhea, stomach pain, and constipation.
Although the FDA and Novo Nordisk, the maker of Ozempic, have already collected and are testing thousands of samples, they have warned that some counterfeit products may still be available for purchase.
Therefore, wholesalers, retail pharmacies, healthcare professionals and patients are advised to check the semaglutide they have received to ensure that it is not part of a mis-delivery marked with batch number NAR0074 and serial number 430834149057.
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Watch out for fakes
The FDA and Novo Nordisk are currently testing the collected samples to determine their content, safety and efficacy. So far, they have determined that the pen labels on the products, information from healthcare professionals and patients, and the packaging that the medicine is in are all fake.
Importantly, the needles were also found to be counterfeit, meaning their sterility could not be confirmed and could increase patients’ risk of infection.
Anyone currently in possession of a semaglutide product is advised to take a close look before using, selling, or otherwise distributing it to verify not only the lot and serial number, but also the product’s labeling and packaging. FDA encourages consumers to compare photos. posted genuine Ozempic packaging on their website for the products they supplied due to differences in colors, labels and appearance.
The agency also reminded pharmacies to buy Ozempic only through authorized Novo Nordisk dealers and patients to only get it from a state-licensed pharmacy with a prescription. Anyone handling the product is advised to examine it carefully for tampering or counterfeiting.
What is Ozempic (semaglutide)?
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Weight loss drugs became one of the hottest health topics in 2023. Originally the most popular drug for diabetes, semaglutide has gained immense popularity for its ability to promote rapid weight loss in patients.
Semaglutide is the generic name for Wegovy, which is approved for weight loss, and Ozempic, which is used to treat diabetes. Both are manufactured 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 your brain’s appetite center to reduce hunger and increase satiety, making it easier to manage hunger pangs, stick to smaller and fewer meals, and overcome emotional or boredom eating.
Semaglutide has been shown to help patients lose 15 to 20 percent of their body weight, but it is also expensive and often not covered by insurance if used primarily for weight loss.
The drugs, which cost about $1,000 a month for weekly injections, have also been found to have serious drawbacks, one of which is the tendency for consumers to gain weight back after stopping treatment. The risk of pancreatitis, gallstone disease and gastroparesis is also low.
Semaglutide has been in short supply for about two years, largely because it has been increasingly prescribed to patients without diabetes.
While Ozempic was approved for diabetes treatment as early as 2017, Wegovy was not approved for use in weight loss until 2021, causing an explosion in demand.
As USA TODAY previously reported, Novo Nordisk has struggled to keep up with huge demand, as data released in September showed that prescriptions increased in major metropolitan areas in the first year of Wegovy’s approval. In some places, such as Cleveland and Seattle, semaglutide prescriptions increased by 481% and 351%, respectively.
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