July 26 (Reuters) - The U.S. Food and Drug
Administration on Friday warned patients and doctors about
dosing errors associated with compounded 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 be related to
overdoses due to patients incorrectly self-administering the
compounded drug and healthcare providers miscalculating doses.
The FDA flagged the higher risk to patients from the use of
compounded drugs, which may contain additional ingredients, and
may contribute to potential medication errors. It urged
healthcare providers and compounders to provide the appropriate
syringe size and counsel patients on how to measure the dose.
Overdoses with these drugs could cause adverse effects
including severe nausea, vomiting and low blood sugar levels.
The explosive demand has created a huge shortage and fueled
a booming global market for cheaper versions, sometimes even
counterfeits.
The FDA has also expressed serious concerns about the
prevalence of fake versions of Novo's diabetes drug Ozempic and
other drugs approved for weight loss, including Novo's Wegovy
and Eli Lilly's ( LLY ) Zepbound.
Semaglutide, the key ingredient in Wegovy and Ozempic,
belongs to the GLP-1 class of drugs, which work by helping
control blood sugar levels and triggering a feeling of fullness.
Novo's Wegovy is available as single-dose pre-filled pens
that deliver a preset dose for once weekly dosing, while Ozempic
is available as multiple-dose pre-filled pens for single-patient
use, designed for once-weekly dosing.
(Reporting by Mariam Sunny in Bengaluru; Editing by Shinjini
Ganguli and Sriraj Kalluvila)