The U.S. Food and Drug Administration issued a warning on Friday regarding dosing errors associated with compounded versions of Novo Nordisk’s weight-loss and diabetes medications. The FDA has received reports of adverse events, some resulting in hospitalization, which may be linked to overdoses caused by patients incorrectly self-administering the compounded drugs and healthcare providers misjudging doses.
The FDA emphasized the heightened risk to patients when using compounded drugs, as they may contain additional ingredients that could contribute to medication errors. Healthcare providers and compounders are urged to provide the appropriate syringe size and educate patients on how to accurately measure their doses to prevent overdosing.
An overdose of these drugs could lead to severe side effects such as nausea, vomiting, and low blood sugar levels. The surge in demand has led to a significant shortage and a thriving global market for cheaper, and sometimes counterfeit, versions of these medications.
The FDA has also expressed concerns about the prevalence of fake versions of Novo’s diabetes drug Ozempic and other weight loss medications, including Novo’s Wegovy and Eli Lilly’s Zepbound.
Semaglutide, the main component in Wegovy and Ozempic, belongs to the GLP-1 class of drugs, which help regulate blood sugar levels and induce a sensation of fullness. Wegovy is available in single-dose pre-filled pens for once-weekly dosing, while Ozempic comes in multiple-dose pre-filled pens for single-patient use, designed for weekly dosing.