FDA issues alert about dosing errors associated with compounded injectable semaglutide products

FDA

FDA issues alert about dosing errors associated with compounded injectable semaglutide products

In an FDA MedWatch update, the agency has issued an alert to HCPs, compounders, and patients about dosing errors that can occur as a result of patients measuring and self-administering incorrect doses of injectable semaglutide products. FDA has received reports of adverse events, including some that have required hospitalization. 

“Many of the patients who received vials of compounded semaglutide lacked experience with self-injections, according to the adverse event reports. Unfamiliarity with withdrawing medication from a vial into a syringe and coupled with confusion between different units of measurement (e.g., milliliters, milligrams and “units”) may have contributed to dosing errors,” FDA stated in the MedWatch alert. The agency is encouraging patients to discuss how to properly measure and administer their dose of compounded semaglutide with their HCP or compounder, and it is advising that HCPs and compounders give patients the appropriate syringe size for the intended dose and tell patients how to measure the intended dose using the syringe.

Read the full FDA MedWatch alert.