Topline
The Food and Drug Administration on Friday issued a notice to health care providers and patients about dosing errors with compounded versions of Novo Nordisk’s weight loss drug Ozempic, after the agency received reports of possible overdoses from patients who took up to 20 times the prescribed dosage.
The agency received reports of patients taking up to 20 times the prescribed dosage, causing some to … [+]
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Key Facts
The FDA received an unspecified number of reports of dosing errors involving compounded semaglutide—the active ingredient in Ozempic and Wegovy—from patients prescribed the drug, including some who required medical attention or hospitalization, according to the agency.
A “majority” of the reports indicated patients mistakenly drew up more than the prescribed dose from a multiple-dose vial while self-administering the drug, with patients taking between five and 20 times the intended dose, the FDA said.
Adverse events reported by the dosing errors included nausea, abdominal pain, fainting, acute pancreatitis and gallstones, among others, the FDA said.
The reports also indicated patients were unfamiliar and untrained with how to measure the dose using a syringe, the FDA said, including one report from a patient who said they had challenges understanding instructions from their health care provider.
Several reports described health care providers prescribing incorrect doses, including one health care provider who intended to prescribe a 5-unit dose but prescribed a 25-unit dose instead, while another prescribed a 20-unit dose instead of a 2-unit dose to a patient who experienced nausea and vomiting.
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Key Background
The FDA issued a warning last year about compounded semaglutide, suggesting patients shouldn’t use a compounded drug if an approved drug is available. Compounded drugs—medications combining or changing ingredients—aren’t FDA-approved or regulated, as the agency is also unable to verify the safety of the medications. The FDA advised patients to be cautious about purchasing semaglutide products, as some compounded semaglutide drugs may not include the same active ingredients as approved medications and may contain salt formulations, which the FDA noted were neither safe nor effective.
Tangent
Novo Nordisk has sued more than a dozen medical spas, wellness clinics and pharmacies over the last year for the alleged sale of compounded versions of Ozempic and Wegovy as they periodically appear on the FDA’s drug shortage list.
