The FDA has issued a warning urging people to avoid using off-brand or compound formulations of the popular semaglutide drugs Ozempic, Wegovy and Rybelsus.
Semaglutide drugs such as Ozempic, Wegovy and Rybelsus have become the subject of a global shortage, with demand for the trending drugs outstripping supply. As a result, some people have turned to compound pharmacies for versions of diabetes and weight loss drugs. Now the FDA is warning consumers that these off-label versions could be potentially dangerous.
In a statement released May 31 titled Semaglutide-Containing Drugs Marketed for Type 2 Diabetes or Weight Loss, the FDA referred to reports of adverse events associated with some forms of the compound semaglutide. Specifically, officials have named compounded versions that may contain ingredients similar to the active ingredient semaglutide but chemically different because they’re in salt form. The agency has cautioned that it does not review these compound versions of semaglutide for safety or effectiveness.
What is compound semaglutide?
Compound drugs are created by combining or altering ingredients to create drugs tailored to the needs of a specific individual. There are approximately 7,500 compound pharmacies in the United States. When the FDA’s drug shortage website lists a drug as currently in shortage, as is the case with the semaglutide drugs Ozempic, Wegovy, and Rybelsus, compounding pharmacies can purchase semaglutide from drug ingredient manufacturers, mix it with other compounds, and prepare a version of the drug if they meet certain requirements of the Federal Food, Drug, and Cosmetics (FD&C) Act. However, the agency does not review these compounded versions for safety, efficacy, or quality.
What is the difference between semaglutide and semaglutide sodium?
Some compounding pharmacies have dispensed versions of the drug made with a different active ingredient called semaglutide sodium. The FDA has labeled these particular versions as potentially dangerous.
Patients should be aware that some products sold as semaglutide may not contain the same active ingredient as FDA-approved semaglutide products and may be saline formulations, the FDA wrote. Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.
Adverse events from some compound forms of semaglutide
The FDA noted that it has received reports of adverse events after patients have used the compound semaglutide and has encouraged the public to report any additional adverse events to the FDA through the MedWatch Adverse Event Reporting Program.
The FDA has received reports that compounders may use saline forms of semaglutide in some cases, including semaglutide sodium and semaglutide acetate. The forms of salt have different active ingredients than what it is [sic] used [in] the approved drugs, which contain the basic form of semaglutide. The agency is unaware of any basis for compounding using the salt forms that would meet FD&C requirements for the types of active ingredients that can be compounded, the FDA said.
Is there a generic version of Wegovy, Ozempic or Rybelsus?
In its statement, the federal agency stressed that there are currently only three FDA-approved semaglutide products Ozempic and Wegovy, which are injectable, and Rybelsus, which is an oral tablet, all available with a prescription only, and that there are no versions approved generics .
The FDA is unaware of any basis for compounding a drug using semaglutide salts that meet federal requirements, the agency added.
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