The US Meals and Drug Administration says some individuals have been hospitalized with signs that could be associated to overdoses from injectable weight-loss medication.
The company alerted healthcare suppliers and sufferers on Friday, saying it obtained experiences that some individuals sought medical consideration or required hospitalization after taking incorrect doses of “compounded” semaglutide merchandise.
Compounded prescription drugs are basically copies of authorized drugs that the FDA permits throughout a scarcity however which haven’t gone by the standard FDA approval course of. That is presently the case for semaglutide, which is offered underneath the model names Ozempic and Wegovy.
Compounded semaglutide is a barely extra complicated story, nevertheless. The Danish pharmaceutical firm Novo Nordisk has a patent on the semaglutide molecule and does not provide it on the market for compounding. This has triggered confusion over the place some pharmacies are sourcing components.
“Compounded medication pose a better danger to sufferers than FDA-approved medication as a result of compounded medication don’t endure FDA premarket evaluate for security, high quality or effectiveness,” the alert stated.
The eating regimen trade has exploded lately partially because of the FDA’s 2021 choice to approve semaglutide — a drug initially supposed to deal with kind 2 diabetes — for weight problems administration. Novo Nordisk’s injectable drugs, Wegovy and Ozempic, shortly gained consideration from shoppers, even amongst those that could not afford the steep price ticket.
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The FDA didn’t share the variety of experiences it obtained however stated the opposed well being occasions could also be associated to incorrect dosing of compounded semaglutide merchandise.
“Dosing errors have resulted from sufferers measuring and self-administering incorrect doses of the drug and well being care suppliers miscalculating doses of the drug,” the FDA stated.
The alert added that some sufferers administered 5 to twenty instances greater than supposed, and one healthcare supplier prescribed at the least three sufferers 20 models as an alternative of two.
The FDA additionally stated there aren’t any trade requirements relating to compounded semaglutide since merchandise can come in several concentrations, containers, syringe sizes, and directions.
“FDA encourages compounders, well being care suppliers, and sufferers to report opposed occasions and drugs errors related to compounded semaglutide merchandise to FDA’s MedWatch Antagonistic Occasion Reporting program,” the company stated.
