(Reuters) -The U.S. Food and Drug Administration on Friday warned patients and doctors about dosing errors linked to compounded versions of Novo Nordisk’s (NYSE:) weight loss and diabetes drugs.
The health regulator said it has received reports of side effects, some requiring hospitalisation, which may be linked to overdoses due to patients incorrectly self-administering the compounded drug and healthcare providers miscalculating doses.
The FDA has noted the increased risk to patients due to the use of compounded medications, which may contain additional ingredients and contribute to potential medication errors. It urged healthcare providers and compounding companies to provide the correct syringe size and advise patients on measuring the dose.
Overdoses of these drugs can cause side effects, including severe nausea, vomiting, and low blood sugar levels.
The explosive demand has created a massive shortage and fueled a booming global market for cheaper versions, sometimes even counterfeits.
The FDA has also raised serious concerns about the prevalence of counterfeit versions of Novo’s diabetes drug Ozempic and other drugs approved for weight loss, including Novo’s Wegovy and Eli Lilly (NYSE:)’s Zepbound.
Semaglutide, the main ingredient in Wegovy and Ozempic, belongs to the GLP-1 class of drugs, which work by controlling blood sugar levels and causing a feeling of fullness.
Novo’s Wegovy is available as single-dose prefilled pens that deliver a preset dose for once-a-week dosing, while Ozempic is available as multi-dose prefilled pens for single-patient use designed for once-a-week dosing.
