(Reuters) – The U.S. Food and Drug Administration on Friday warned patients and doctors about dosing errors linked to combination versions of Novo Nordisk’s weight-loss and diabetes drugs.
The health regulator said it had received reports of adverse events, some requiring hospitalization, that may have been linked to overdoses caused by patients giving themselves incorrectly compounded medication and healthcare providers calculating doses incorrectly.
The FDA noted the high risk to patients of using compounded medications, which may contain additional ingredients and may contribute to potential medication errors. It urged health care providers and compounding drug manufacturers to provide the appropriate syringe size and instruct patients on how to measure the dose.
Overdose of these medications can lead to side effects including severe nausea, vomiting, and low blood sugar levels.
The huge demand has created a huge shortage and led to a booming global market for cheaper, and sometimes even counterfeit, versions.
The FDA has also expressed serious concerns about the spread of counterfeit versions of Novo’s diabetes drug Ozempic and other approved weight-loss drugs, including Novo’s Wegovy and Eli Lilly’s (NYSE:) Zepbound.
Semaglutide, the main ingredient in Wegovy and Ozempic, belongs to the GLP-1 class of drugs, which work to help control blood sugar levels and induce feelings of fullness.
Novo’s wegovy is available as single-dose prefilled pens that provide a predetermined dose to be taken once weekly, while Ozempic is available as multi-dose prefilled pens for single-patient use, designed to be taken once weekly.