Los Angeles, CA – The US Food and Drug Administration issued an alert concerning potential overdoses from counterfeit injectable weight-loss drugs. Reports have surfaced detailing instances where individuals have self-administered incorrect doses of compounded semaglutide products, leading to hospitalization and severe health consequences.
Compounded pharmaceuticals, including semaglutide, are replicas of approved medications that have not undergone the usual FDA approval process. This particular case involves semaglutide, marketed under the brand names Ozempic and Wegovy. Novo Nordisk, the pharmaceutical company holding the patent for semaglutide, does not provide the molecule for compounding, raising concerns about the origins of some pharmacies’ ingredients.
The FDA expressed that compounded drugs pose a higher risk than FDA-approved medications due to the lack of premarket review for safety, quality, or effectiveness. The rise in popularity of semaglutide for obesity management, originally designed for type 2 diabetes treatment, has fueled a surge in the weight-loss industry. Novo Nordisk’s injectable medications, Wegovy and Ozempic, garnered attention, even among those seeking more affordable options.
The FDA emphasized the importance of reporting adverse events and medication errors linked to compounded semaglutide products to their MedWatch Adverse Event Reporting program. With no industry standards in place for compounded semaglutide, varying concentrations, container types, syringe sizes, and instructions have contributed to dosing errors ranging from 5 to 20 times the intended amount. Healthcare providers have unfortunately miscalculated dosages, underscoring the potential dangers associated with counterfeit weight-loss drugs.
As the investigation into overdoses related to knock-off semaglutide products continues, the FDA remains vigilant in warning both healthcare professionals and patients about the risks associated with compounded medications. The alert serves as a crucial reminder of the importance of adhering to FDA-approved drugs to ensure the safety and well-being of individuals seeking weight-loss solutions.