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alert date:

July 26, 2024

FDA Alerts Providers, Compounders, and Patients of Dosing Errors with Compounded Semaglutide

The FDA issued an alert to providers, compounders, and patients of dosing errors associated with compounded injectable semaglutide products, due to reports of adverse events, some requiring hospitalization, that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products. Dosing errors have resulted from patients measuring and self-administering incorrect doses of the drug and health care providers miscalculating doses of the drug. The FDA encourages patients to talk with their health care provider or compounder about how to measure and administer the intended dose of compounded semaglutide. Many of the patients who received vials of compounded semaglutide lacked experience with self-injections, according to the adverse event reports Adverse events included gastrointestinal effects (e.g., nausea, vomiting, abdominal pain), fainting, headache, migraine, dehydration, acute pancreatitis and gallstones.

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