The FDA warned consumers this week not to use off-brand versions of popular weight-loss drugs Ozempic, Rybelsus and Wegovy, saying they may contain different ingredients from the brand-name drugs that are neither safe nor effective.
In the warning, agency officials said they have received reports of problems stemming from “compounded” versions of the drug’s active ingredient, semaglutide.
Compounding is the mixing of different drugs “to create a medication tailored to the needs of an individual patient.” It is sometimes permitted in pharmacies when there are drug shortages, but must meet certain standards outlined in the Federal Food Drug and Cosmetic Act (FD&C).
Ozempic and Wegovy were both listed on the drug-shortage list as of May 2023. The warning also listed the drug Rybelsus, which is an oral version.
“Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs,” the agency wrote.
Compounded semaglutide often contains a version of semaglutide used in labs and not verified for patient use, the FDA warned. Further, the FDA warned that it has gotten reports that some compounded semaglutide contains salt, which changes the active ingredient in the drug.
“The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded,” the agency wrote.
Some states have been sounding the alarm as off-brand versions of Ozempic and Wegovy have flooded the markets. Regulators in Louisiana, West Virginia, Mississippi, and North Carolina raised concerns recently about the safety of some of the compounded drugs, and states have tried to take action to curb their manufacturing.
Ozempic is intended to treat Type 2 Diabetes, but it is also a lower-dosage version of the Wegovy drug, which is approved for weight loss. As demand for weight-loss drugs has skyrocketed, supply for both drugs has plummeted – which has acutely affected diabetes patients who rely on Ozempic for treatment.
