FDA Issues Warning On Overdoses Of Compounded Semaglutide For Weight Loss Due To Dosing Errors

In a recent alert, the U.S. Food and Drug Administration (FDA) has warned healthcare providers, patients, and compounders about the risks of dosing errors associated with compounded semaglutide injectables, which are being used off-label for weight loss. The FDA has received numerous reports of adverse events and hospitalizations due to miscalculated doses of these products.

Compounded Semaglutide Injectables and Their Risks

Semaglutide, a glucagon-like-peptide-1 (GLP-1) receptor agonist, is FDA-approved for the treatment of type 2 diabetes under the brand names Wegovy, Ozempic, and Rybelsus. Wegovy and Ozempic are administered via pre-filled pens. In recent times, compounded versions of semaglutide, often mixed with other drugs, have been marketed for weight loss, presenting unique challenges and risks.

Key Issues Identified by the FDA:

Miscalculated Doses: Both patients and healthcare providers have made errors in dosing. Patients unfamiliar with self-injection techniques have administered incorrect dosages, while some providers have also miscalculated the prescribed doses.

Adverse Events: Reports have highlighted adverse effects including gastrointestinal issues, fainting, headaches, migraines, dehydration, acute pancreatitis, and gallstones.

Compounded Drug Variability: Compounded semaglutide products differ in concentration, container size, and packaging. The lack of standardization can lead to confusion, with doses often measured in “units” instead of milligrams or milliliters, further complicating accurate dosing.

Recommendations to Prevent Dosing Errors

The FDA recommends the following measures to minimize the risk of dosing errors:

Proper Syringe Provision: Healthcare providers and compounders should supply patients with the correct syringe size for the intended dose and thoroughly instruct them on how to measure and administer the dose.

Understanding Concentrations: Providers must be aware of the various concentrations of compounded semaglutide when prescribing it. If there is any uncertainty, they should consult the compounder for assistance in calculating the correct dose.

Reporting Adverse Events: Healthcare professionals, compounders, and patients are urged to report any adverse events or medication errors associated with compounded semaglutide to the FDA’s MedWatch Adverse Event Reporting program.

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Tags: Type 2 Diabetes