FDA Posts Warning on Compounded Semaglutide Products, Citing Reports of Adverse Events

The US Food and Drug Administration (FDA) on May 30 posted a warning on its website in response to reports of adverse events associated with compounded formulations of semaglutide, the glucagon-like peptide-1 (GLP-1) receptor agonist approved in various dosages and administration routes for treatment of type 2 diabetes in adults (Ozempic, Rybelsus) and for overweight and obesity in adults and children aged ≥12 years (Wegovy).

Due to immediate and overwhelming demand for both Ozempic and Wegovy, manufacturer Novo Nordisk has been unable to support supply of the drugs and as of this writing they remain on the FDA’s Drug Shortages list. When a drug is listed here as “Currently in shortage” drug compounders may be able to prepare a compounded version if it meets specific requirements of the Federal Food, Drug, and Cosmetic Act.

The FDA states that it does not review compounded versions of drugs for safety, efficacy, or quality. The agency warns further that purchasing medications online, where many people are seeking the scarce weight loss drug, from unregulated and unlicensed sources, can cause exposure to potentially harmful products that have not been evaluated appropriately.

Although the FDA does not provide specifics on adverse events reported, the concern is that compounding pharmacies, unable to obtain the specific semaglutide molecule, may be using semaglutide sodium or semaglutide acetate, salt forms of the drug that are not identical to the active ingredient in approved versions of the drug.

In a letter to the National Association of Boards of Pharmacy (NABP), dated April 27, 2023, the FDA stated: “We are not aware of any basis for compounding a drug using these semaglutide salts that would meet federal law requirements that limit the types of active ingredients that can be used in compounding.”

According to information on the FDA Drug Shortages list, the 2 highest doses of Wegovy are available but supply of the 3 lower doses will be limited until September. On May 4, 2023, Novo Nordisk said in a statement that, while it has “taken significant measures to increase capacity,” it can currently only provide limited quantities of the 3 lower doses and anticipates patients will have difficulty filling prescriptions for these through September.

FDA encourages health care professionals, patients, and compounders to report adverse events or quality problems with these or any medications to FDA’s MedWatch Adverse Event Reporting program.