Federal officials are warning users of the popular diabetes drug Ozempic to be cautious of counterfeit versions that have been sold through legitimate sources. The Food and Drug Administration (FDA) has recently seized "thousands of units" of counterfeit Ozempic 1 milligram injections as part of an ongoing investigation, according to a consumer alert issued on Thursday. Although the drugs have been linked to five reports of illness, none of the cases were severe.
The FDA has identified specific counterfeit products with lot number NAR0074 and serial number 430834149057 on the box, advising users not to use them. The agency is currently testing the seized products in collaboration with Ozempic-maker Novo Nordisk. The counterfeit drugs not only mimic the appearance of authentic Ozempic, but also include counterfeit pen labels, cartons, fact sheets, and needles. Novo Nordisk has highlighted the potential infection risk posed by the counterfeit needles, as it remains unclear whether they are sterile.
Ozempic has gained significant popularity this year, largely due to celebrities touting its weight-loss effects. This has led to shortages of the drug, creating an opportunity for fraudsters to sell illegitimate Ozempic-like products to pharmacies. It is unclear whether these counterfeit products are diverted from foreign markets or being produced within the U.S. Last month, the FDA reported three hospitalizations related to suspected counterfeit products containing semaglutide, the active ingredient in Ozempic.
In light of this situation, the FDA is advising retail pharmacies to purchase authentic Ozempic only from authorized distributors, and patients to obtain the drug exclusively from state-licensed pharmacies. The agency encourages consumers to report any suspicious Ozempic packages by calling 800-332-1088 or contacting a state complaint coordinator. The FDA's warning comes as a response to the increasing demand for Ozempic and the subsequent circulation of fake products in the market.
Novo Nordisk, the Danish pharmaceutical company behind Ozempic, has been actively combating counterfeit products. The company acknowledged the current shortage and the challenges it faces in meeting the demand for Ozempic throughout 2024. The drug contains semaglutide, a potent medication that mimics the effects of the GLP-1 hormone, which helps individuals feel full after eating. Semaglutide is also found in another Novo Nordisk drug called Wegovy, which was approved by the FDA for chronic weight management earlier this year.
The issue of counterfeit Ozempic has been a concern for regulators beyond the U.S. The Danish Medicines Agency reported 26 websites illegally selling alleged Ozempic and Wegovy products, and the European Medicines Agency warned against counterfeit Ozempic pens with German labels falsely claiming to be diabetes medicine. These incidents have shed light on various side effects associated with Ozempic and Wegovy, including "Ozempic butt," where users claim their buttocks have flattened along with their stomachs, and "Ozempic finger," where finger and wrist sizes rapidly shrink.
Despite the potential risks, the popularity of Ozempic remains high, driven by its weight-loss effects and celebrity endorsements. Users have reported serious side effects such as suicidal thoughts and self-harm. The FDA's warning serves as a reminder for patients to exercise caution and verify the authenticity of their medications to ensure their safety.
