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US FDA flags dosing risks from compounded versions of Novo's weight-loss drug
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US FDA flags dosing risks from compounded versions of Novo's weight-loss drug
Jul 26, 2024 8:43 AM

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)

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