The FDA says patients may be overdosing on imitation semaglutide weight-loss drugs because the directions are unclear
The FDA warned that incorrect dosing of compounded semaglutide products may be causing health problems.
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- The FDA said people may be overdosing on knock-off semaglutide weight-loss drugs.
- Consumers are self-administering incorrect doses.
- Reports found some people administered 5 to 20 times more semaglutide than intended.
The US Food and Drug Administration says some people have been hospitalized with symptoms that may be related to overdoses from injectable weight-loss drugs.
The agency alerted healthcare providers and patients on Friday, saying it received reports that some people sought medical attention or required hospitalization after taking incorrect doses of "compounded" semaglutide products.
Compounded pharmaceuticals are essentially copies of approved medications that the FDA allows during a shortage but which have not gone through the usual FDA approval process. This is currently the case for semaglutide, which is sold under the brand names Ozempic and Wegovy.
Compounded semaglutide is a slightly more complex story, however. The Danish pharmaceutical company Novo Nordisk has a patent on the semaglutide molecule and doesn't offer it for sale for compounding. This has caused confusion over where some pharmacies are sourcing ingredients.
"Compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, quality or effectiveness," the alert said.
The diet industry has exploded in recent years in part due to the FDA's 2021 decision to approve semaglutide — a drug originally intended to treat type 2 diabetes — for obesity management. Novo Nordisk's injectable medications, Wegovy and Ozempic, quickly gained attention from consumers, even among those who couldn't afford the steep price tag.
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The FDA did not share the number of reports it received but said the adverse health events may be related to incorrect dosing of compounded semaglutide 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 said.
The alert added that some patients administered 5 to 20 times more than intended, and one healthcare provider prescribed at least three patients 20 units instead of two.
The FDA also said there are no industry standards regarding compounded semaglutide since products can come in different concentrations, containers, syringe sizes, and instructions.
"FDA encourages compounders, health care providers, and patients to report adverse events and medication errors associated with compounded semaglutide products to FDA's MedWatch Adverse Event Reporting program," the agency said.