FDA flags dosing risks from compounded versions of Novo’s weight-loss drug

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 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.