The US Food and Drug Administration warned patients of fake Ozempic that has been circulating through wholesalers, retail pharmacies and health care practitioners as Novo Nordisk’s drug remains in high demand.
The federal agency said it has seized “thousands of units” of counterfeit Ozempic and advised patients to check the product they received and throw it away if it’s labeled with the lot number NAR0074 and serial number 430834149057.
“Some counterfeit products may still be available for purchase,” the FDA said in a warning issued Thursday.
Five people have become sick in connection with the products, although none of the cases has been serious, the FDA said.The agency added that the counterfeit Ozempic even touts similar adverse reactions as the real thing, such as nausea, vomiting, diarrhea, abdominal pain and constipation.
The regulator assured that it was testing the seized products with Novo Nordisk, but does “not yet have information about the drugs’ identity, quality or safety.” The FDA said the pen label, carton, information for patients and health care professionals, and needles that come with the injectors are also counterfeit.
“The sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products,” the FDA said.
Shares of Novo Nordisk, which are up 48% this year, were recently off 0.9%.
Ozempic — which hasn’t even been approved by the FDA as a weight-loss solution — is a once-weekly shot initially designed to treat Type 2 diabetes.
However, it has gained immense mainstream popularity this year for its “miraculous” pound-shedding effects, as shown off by celebrities like Amy Schumer, Chelsea Handler and Tracy Morgan, and endorsed by Oprah, whose WeightWatchers company recently acquired Sequence, a tele-health subscription service that prescribes Ozempic.
When The Post sought comment from the Denmark-based pharmaceutical giant behind the blockbuster drug, a spokesperson pointed to a statement on its site, which said that it is in an “active fight against counterfeit Novo Nordisk products.”
The statement addressed the adverse effects, and clarified that it’s still unclear “if these incidents included legitimate product or the counterfeit product.”
Ozempic injections contain semaglutide, a type of strong medication that mimics the actions of the GLP-1 hormone, which the pancreas releases after eating that makes people feel full.
Semaglutide is the same medication in Wegovy, a fellow Novo Nordisk-made drug initially intended to treat diabetes, but approved by the FDA for chronic weight management back in 2021.
The FDA is not the first regulator to raise concerns about so-called “faux-zempic.” The Danish Medicines Agency said in a statement issued on Oct. 31 that authorities know of 26 websites illicitly selling what they claim to be Ozempic and Wegovy.
The European Medicines Agency also warned against counterfeit Ozempic pens in October, which the organization said boasted labels in German “falsely labeled as diabetes medicine Ozempic” with 1 milligram of semaglutide for injection.
Bizarre side effects that have come to light since the Ozempic and Wegovy craze took effect hasn’t deterred Hollywood and non-celebrities alike from getting their prescriptions of the insulin-regulating semaglutide injections — so much so that Novo Nordisk said it expects shortages of the drugs to persist throughout 2024.
Adverse effects have included “Ozempic butt,” where users are claiming that their derrières have flattened along with their tummies, as well as “Ozempic finger,” where finger and wrist sizes were rapidly shrinking too, causing women to fear that their engagement rings would fall off.
Among the latest — and much more serious — side effect saw patients reporting that the medicines triggered thoughts of suicide and self-harm.
Credit: Source link
