- The FDA says people may be overdosed on counterfeit weight-loss drug semaglutide.
- The consumer himself gave the wrong dose.
- Reports found some people were given 5 to 20 times more semaglutide than intended.
The US Food and Drug Administration says several people have been hospitalized with symptoms possibly related to an overdose of the injected weight-loss drug.
The agency warned health care providers and patients on Friday, saying it had received reports that some people sought medical attention or required hospitalization after taking the wrong dose of a “compounded” semaglutide product.
Counterfeit drugs are essentially copies of FDA-approved drugs that are allowed during shortages but have not gone through the regular FDA approval process. This is true for semaglutide, which is sold under the brand names Ozempic and Wegovy.
However, compounded semaglutide is a slightly more complicated story. Danish pharmaceutical company Novo Nordisk owns the patent on the semaglutide molecule and does not offer it for sale in compounded form. This has led to confusion about where some pharmacies get their ingredients from.
“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 warning said.
The diet industry has boomed in recent years, in part because of the FDA’s decision in 2021 to approve semaglutide — a drug originally intended to treat type 2 diabetes — to manage obesity. Novo Nordisk’s injectable drugs, Wegovy and Ozempic, have quickly caught on with consumers, even among those who can’t afford the high price tag.
The FDA did not disclose the number of reports it received but said the adverse health events were likely related to improper dosing of the compounded semaglutide products.
“Dosing errors occur when patients measure and self-administer the wrong dose of medication and when healthcare providers miscalculate the dose of medication,” the FDA said.
The warning added that some patients were given 5 to 20 times more than intended, and one health care provider prescribed at least three patients 20 units instead of two.
The FDA also said there is no industry standard for compounded semaglutide because products can be available in varying concentrations, containers, syringe sizes and instructions.
“FDA encourages compounders, healthcare 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.
