The US Food and Drug Administration warned patients about counterfeit Ozempic, which has circulated through wholesalers, retail pharmacies and healthcare professionals, as Novo Nordisk’s drug remains in high demand.
The federal agency said it has seized “thousands of units” of counterfeit Ozempic and urged patients to check the product they received and throw it away if it has 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 been sickened by the products, though none have been serious, the FDA said. The agency added that counterfeit Ozempic even presents side effects similar to the real thing, such as nausea, vomiting, diarrhea, stomach pain and constipation.
The regulatory authority assured that it will test the seized products at Novo Nordisk, but it “does not yet have information about the identity, quality or safety of the drugs”. The FDA said the pen’s label, box, information for patients and healthcare professionals, and the needles that come with the syringes are also counterfeit.
“The sterility of the needles cannot be confirmed, increasing the risk of infection in patients using counterfeit products,” the FDA said.
Novo Nordisk shares, which have gained 48% this year, recently fell 0.9%.
Ozempic—not even approved by the FDA as a weight loss solution—is a once-weekly dose that was originally designed to treat type 2 diabetes.
However, it has gained massive mainstream popularity this year for its miraculous weight-loss effects, as evidenced by celebrities like Amy Schumer, Chelsea Handler and Tracy Morgan, and Oprah, whose WeightWatchers company recently bought Sequence, a telehealth subscription. service prescribing Ozempic.
When The Post sought comment from the Danish pharmaceutical giant behind the blockbuster drug, a spokesperson referred to a statement on its website that it is actively fighting counterfeit Novo Nordisk products.
The statement addressed the adverse effects and clarified that it remains unclear “whether these events involved legitimate product or counterfeit product.”
Ozempic injections contain semaglutide, a type of strong drug that mimics the action of the GLP-1 hormone released by the pancreas after eating, which makes people feel full.
Semaglutide is the same drug in Wegovy, a drug made by Novo Nordisk that was originally intended to treat diabetes but was approved by the FDA for chronic weight management in 2021.
The FDA is not the first regulator to express concern about so-called faux-zempic. The Danish Medicines Agency said in a statement on October 31 that authorities are aware of 26 websites illegally selling Ozempic and Wegovy.
The European Medicines Agency also warned in October about counterfeit Ozempic pens, which the organization said had German-language labels mislabeling the diabetes drug Ozempic as containing 1 milligram of semaglutide for injection.
The bizarre side effects revealed since the Ozempic and Wegovy craze took hold haven’t stopped Hollywood and non-celebs from getting insulin-regulating semaglutide injections — so much so that Novo Nordisk said it expects a shortage of the drug throughout 2024.
Adverse effects have included Ozempic backside, where users claim their stomachs have flattened out with their stomachs, and Ozempic finger, where the size of fingers and wrists also decreased rapidly, leading women to fear their engagement rings falling off.
Among the most recent and much more serious side effects, patients reported that the drugs caused suicidal thoughts and self-harm.
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