As a result, some patients took five to 20 times the prescribed dose, with several requiring medical attention or hospitalization. These patients administered compounded versions of the drug from compound pharmacies rather than drug manufacturers, the agency said. Dosing errors may have occurred due to patients’ lack of experience with self-dosing, and some occurred due to doctors’ dosing miscalculations.
Currently, semaglutide is only available as a brand prescription with no approved generic versions. But since Ozempic and Wegovy are in shortage, compounders may prepare a compounded version of the drug if they meet certain requirements. However, the FDA said these versions differ from approved semaglutide drugs, as compound drugs “do not undergo FDA premarket review for safety, effectiveness or quality.
” Most of the reports came from patients who were unfamiliar with measuring the intended dose and who overdosed while using a multidose syringe. Patients were instructed to administer five units, or a 0.05-milliliter dose, but drew up 0.
5 milliliters (50 units) of semaglutide instead. “In one reported case, it was difficult for the patient to obtain clarity on dosing instructions from the telemedicine provider, who prescribed the compounded semaglutide, leading the patient to conduct an online search for medical advice and resulting in the patient taking five times the intended dose,” the FDA wrote. Some providers also miscalculated the dose when converting units.
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