Top Line
The U.S. Food and Drug Administration notified health care providers and patients on Friday about a dosing error with a compounded version of Novo Nordisk Inc.’s weight-loss drug Ozempic after the agency received reports of a possible overdose from patients who took up to 20 times the prescribed dose.
Officials say patients were taking 20 times the prescribed dose, with some … [+]
Key Facts
The FDA has received numerous reports of dosing errors with the combination of semaglutide, the active ingredient in Ozempic and Wegovy, from patients who were prescribed the drugs, including those who required a doctor’s visit or hospitalization. according to To the agency.
The FDA said the “vast majority” of reports indicate that patients were self-administering the drug when accidentally taking more than the prescribed dose from a multi-dose vial, resulting in taking between five and 20 times the intended dose.
According to the FDA, adverse events reported as a result of the dosing error included nausea, abdominal pain, fainting, acute pancreatitis and gallstones.
The FDA said the reports also indicated patients were unfamiliar with and lacked training in how to use syringes to measure out doses, and some reported having trouble understanding instructions from health care providers.
In some reports, health care providers prescribed incorrect doses, with one provider prescribing a 25-unit dose when he meant to prescribe a 5-unit dose, and another prescribing a 20-unit dose instead of a 2-unit dose for a patient who experienced nausea and vomiting.
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Main Background
The FDA issued A warning was issued last year about compounded semaglutide, suggesting that patients should not use compounded versions when approved versions are available. Compounded versions (drugs with ingredients combined or changed) are not approved or regulated by the FDA, and the agency cannot verify their safety. The FDA advised patients to be cautious about purchasing semaglutide products because some compounded semaglutide drugs may not contain the same active ingredient as the approved version and may contain salt formulations, which the FDA has noted are neither safe nor effective.
tangent
Novo Nordisk has sued more than a dozen medical spas, wellness clinics and pharmacies over the past year for selling compounded versions of Ozempic and Wegobee, which regularly appear on the FDA’s drug shortage list.
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