Fauxzempic: FDA Issues Warning on Fake Diabetes Drug Found in US Supply Chain

The US Food and Drug Administration (FDA) warns the public about the circulation of counterfeit versions of Novo Nordisk's diabetes medication Ozempic in the country's drug supply chain.

The FDA is still looking into the fake 1-milligram Ozempic shots, though the agency had already seized thousands. Despite these seizures, the FDA cautioned that some units may still be available for purchase, according to NBC News.

The confiscations occurred in warehouses outside Novo Nordisk's authorized supply chain, indicating a breach in the distribution system. The FDA highlighted that counterfeit needles accompany the seized injections, posing an additional risk as their sterility cannot be verified, heightening the potential for infections in patients.

Serious Health Risks

Further confirmation of the counterfeit nature of these products includes the falsification of pen labels, along with accompanying information about healthcare professionals and patients, as well as the carton. The FDA issued a categorical advisory to drug distributors, retail pharmacies, healthcare practitioners, and patients to scrutinize their Ozempic supplies. Specifically, the FDA urged against the distribution, use, or sale of units labeled with lot number NAR0074 and serial number 430834149057.

Novo Nordisk, the Danish pharmaceutical company, is collaborating with the FDA to conduct rigorous testing on the seized products. The lack of information about the identity, quality, and safety of these drugs raises significant concerns about potential health risks for unsuspecting consumers.

Three people were hospitalized due to counterfeit Ozempic; the FDA reports "five adverse events" from the affected lot, categorizing them as non-serious and consistent with known reactions to authentic Ozempic, including nausea and abdominal issues.

According to People, Ozempic is known to have effects on the digestive system. It has recently come under close review because it could cause problems like ileus, which is a life-threatening bowel stoppage, and gastroparesis, which is when the stomach stops working.

Fake Diabetes Drugs: a Global Concern as Demand Grows

Wegovy is officially allowed to treat obesity, but Ozempic, the diabetes version of Wegovy, is also being used off-label to help people lose a lot of weight. This off-label use has been observed among individuals in both the United States and Europe, reflecting the broader impact of Novo Nordisk's medications beyond their initially approved purposes.

The US, Germany, and Britain seek more supplies of Novo Nordisk drugs like Wegovy and Ozempic than they provide. Thus, Novo Nordisk is limiting US Wegovy dosages.

Drugs obtained through certain direct-to-consumer websites may originate from the "gray market," comprising unlicensed sellers operating outside authorized networks, warns Timothy Mackey, a professor at the University of California, San Diego, specializing in counterfeit medication studies. He explains that gray market manufacturers respond to market demand, often resulting in counterfeit or substandard products, as reported by The New York Times.

The problem of counterfeit Ozempic extends beyond the United States. According to Reuters, instances in Austria involved hospitalizations as a result of the use of fake Ozempic, and in Lebanon, 11 people experienced dangerously low blood sugar after taking suspected fake medication.

Consumers can report suspected fake Ozempic drugs by calling 800-332-1088 or contacting a state complaint coordinator, per ABC News.