FDA Concerned Over Compounded Semaglutide Following Reports of Adverse Events

Concerns about compounded semaglutide have prompted a response from the Food and Drug Administration (FDA) following reports of adverse events.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that is currently approved under 3 brand names: Ozempic, Rybelsus, and Wegovy. Both Ozempic and Rybelsus are indicated as adjuncts to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). Ozempic is also approved to reduce the risk of major cardiovascular (CV) events (eg, CV death, nonfatal MI or nonfatal stroke) in adults with T2DM and established CV disease.

Wegovy is approved as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in: adults with an initial body mass index (BMI) of 30kg/m² or greater (obese) or 27kg/m² or greater (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, T2DM, dyslipidemia); and pediatric patients with an initial BMI at the 95th percentile or greater standardized for age and sex (obesity).

As both Ozempic and Wegovy continue to be listed on the FDA’s Drug Shortages list, compounding of semaglutide is possible when certain requirements are met. However, compounded products have not been reviewed for safety, effectiveness, or quality by the FDA.

Additionally, the agency is reporting that some compounders may be using salt forms of semaglutide (eg, semaglutide sodium, semaglutide acetate), which are different from the active ingredients found in the approved drugs. In a letter to the National Association of Boards of Pharmacy (NABP), 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.”

As such, the FDA is alerting patients and providers that compounded semaglutide may contain the salt forms of the drug, which have not been shown to be safe or effective in clinical trials.

Adverse events related to compounded semaglutide should be reported to the FDA’s MedWatch program.

This article originally appeared on MPR