Downward angle icon Downward angle icon. The FDA has issued a warning about counterfeit injectable semaglutide products. Peter Hansen/Getty Images The FDA said people may be overdosing on counterfeit semaglutide weight-loss drugs. Consumers are self-administering the wrong dose. Some people have reportedly taken five to 20 times the intended amount of semaglutide.
The U.S. Food and Drug Administration says people have been hospitalized with symptoms linked to overdosing on injectable weight-loss drugs.
The agency warned health care workers and patients on Friday after receiving reports of some people needing medical attention or hospitalization after taking the wrong dose of “compounded” semaglutide products.
Combination medications are essentially copies of approved drugs that the FDA cleared during shortages, but they haven’t gone through the normal FDA approval process, which is currently the case with semaglutide, sold under the brand names Ozempic and Wegovy.
But compounded semaglutide is a bit of a complicated story: Danish pharmaceutical company Novo Nordisk holds the patent on the semaglutide molecule and doesn’t sell it for compounding, which has led to confusion about where some pharmacies are sourcing the ingredient.
“Compound drugs have not undergone FDA premarket review for safety, quality, or effectiveness and therefore pose a higher risk to patients than FDA-approved drugs,” the warning states.
The weight-loss industry has exploded in recent years, in part due to the FDA’s approval in 2021 of semaglutide, originally a treatment for type 2 diabetes, as an obesity treatment. Novo Nordisk’s injectable drugs, Wegobee and Ozempic, quickly attracted attention from people who couldn’t afford the high price tag.
Wegovi is an injectable drug used for weight loss. Picture Alliance/Getty Images
The FDA did not disclose how many reports it had received but said the adverse health effects may be related to incorrect administration of semaglutide-containing products.
“The medication errors occurred when patients measured out and self-administered an incorrect dose of medication or when health care professionals miscalculated the medication dose,” the FDA said.
The alert added that some patients had received five to 20 times more than intended, with one healthcare professional prescribing 20 units instead of two to at least three patients.
The FDA also said there is no industry standard for compounded semaglutide because products vary in strength, containers, syringe sizes and instructions.
“FDA encourages dispensers, healthcare providers, and patients to report adverse events or medication errors associated with dispensed semaglutide products to FDA’s MedWatch Adverse Event Reporting Program,” the agency said.
