Alert on Counterfeit Ozempic: Risks and FDA Response to Fake Diabetes Medication
Recent reports have highlighted significant health risks associated with counterfeit and compounded versions of Novo Nordisk’s diabetes drug, Ozempic. In the United States, three individuals experienced dangerously low blood sugar levels in 2023 after using suspected fake Ozempic, as informed by America’s Poison Centers. Additionally, one person in 2023 faced hypoglycemia after injecting a compounded version of the drug.
The growing off-label use of Ozempic and similar diabetes medications for weight loss has led to an increase in demand, subsequently fueling the market for counterfeit versions globally. Incidents of hypoglycemia linked to fake Ozempic were also reported in Austria and Lebanon, with some cases requiring hospitalization. Investigations revealed that these counterfeit products likely contained insulin instead of Ozempic’s active ingredient, semaglutide.
America’s Poison Centers, collaborating with the U.S. Food and Drug Administration (FDA), are investigating these cases. The FDA, acknowledging the receipt of adverse event reports involving both counterfeit and compounded semaglutide products, has not commented on ongoing investigations. In December, the FDA seized thousands of units of counterfeit Ozempic.
Most reports received by America’s Poison Centers in the past year involved non-serious complaints, typically side effects of Ozempic like nausea and vomiting. However, sixty-six reports involved hypoglycemia, primarily with brand-name Ozempic use. Patients experiencing hypoglycemia, a known side effect of Ozempic, especially when used with insulin, often required hospital treatment.
The identification process for these counterfeit semaglutide cases remains undisclosed. Compounded drugs, while legal in the U.S. during drug shortages, face less regulatory scrutiny and have been found to be up to 33% impure in some semaglutide samples, as reported by Novo Nordisk.
This situation underscores the importance of vigilance in the pharmaceutical industry, particularly concerning the integrity and safety of medications.
