Compounded versions of semaglutide, the active ingredient in diabetes and obesity medications Ozempic and Wegovy, have reportedly resulted in at least 100 hospitalizations and 10 deaths, according to Lars Fruergaard Jorgensen, CEO of Novo Nordisk, the maker of Ozempic. Jorgensen expressed deep concern, stating, "Patients believe they're getting a safe product, but I know for a fact they are not getting semaglutide unless it's produced by Novo Nordisk."

The data on these alarming figures originates from the US Food and Drug Administration’s (FDA) adverse event reporting database for semaglutide. It's important to note that the FDA cautions these reports are unverified and do not confirm that the drugs caused the documented harms.

Compounded drugs, created by parties other than the FDA-approved manufacturers, often emerge during drug shortages. Semaglutide and tirzepatide have been on the FDA's shortages list since 2022, leading to a rise in businesses focused on compounded versions. The FDA, along with drug manufacturers and some doctors, warns that these versions carry higher risks due to less stringent regulation and lack of FDA approval.

In October, the FDA reported receiving multiple adverse event reports that may be related to dosing errors with compounded injectable semaglutide products. The agency also warned that some compounders might be selling semaglutide in salt forms, which contain different active ingredients than those in approved drugs, and that counterfeit Ozempic is being sold.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, emphasized that legitimate compounding pharmacies prioritize patient safety within a strict compliance framework. However, the FDA's stance is clear: patients should not use compounded drugs if an approved alternative is available.

The FDA is currently assessing whether the demand for semaglutide in the US exceeds the supply, as semaglutide remains on the shortage list. Novo Nordisk hopes to alleviate this shortage, with the last remaining dose, the lowest dose of Wegovy, now listed as available.

Jorgensen highlighted the collaboration with the FDA, acknowledging their shared concern for patient health and the need for careful consideration of the way forward. The FDA's adverse event database for semaglutide shows 10 deaths among patients potentially associated with compounded semaglutide since 2023, and nearly 500 additional deaths not flagged as compounding-related. The FDA notes the limitations of this data, including the possibility of unverified information, duplicative reports, and incomplete information.

The situation underscores the critical importance of patient safety and the need for vigilance in the procurement and use of medications, especially when compounded versions are involved.