- The FDA said people may be overdosing on the counterfeit semaglutide weight loss drug.
- Consumers are self-administering the wrong dose.
- Some people reportedly received five to 20 times more semaglutide than intended.
The U.S. Food and Drug Administration says people have been hospitalized with symptoms linked to overdosing on injectable weight-loss drugs.
agency Be warned On Friday, the company said it had received reports of health care workers and patients who had required medical attention or hospitalization after taking the wrong amount of compounded medication. Semaglutide products.
Compounded drugs are essentially copies of approved drugs that the FDA has authorized during shortages, but they do not go through the normal FDA approval process. The case of semaglutideIt is 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.
of The diet industry has exploded. In recent years, with the FDA approving semaglutide (originally a type 2 diabetes drug) for obesity management in 2021, Novo Nordisk’s injectable drugs Wegovy and Ozempic have quickly attracted attention from consumers who can’t afford their high prices.
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.
