FDA Issues Warning on Compounded Semaglutide Products
On May 30, 2023, the FDA issued a warning on multiple compounded semaglutide products marketed for type 2 diabetes and weight loss.
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- Compounded forms of semaglutide have been linked to adverse events, leading to FDA-issued warnings. As a result, the FDA recommends that patients avoid compounded semaglutide whenever the approved versions of the drug are available.
Semaglutide has risen in popularity for its ability to approve glycemic control and facilitate weight loss. The drug is a glucagon-like-peptide 1 (GLP-1) receptor agonist known to promote insulin production, reduce appetite, and cause feelings of fullness.
To date, there are three FDA-approved forms of semaglutide: Ozempic, Rybelsus, and Wegovy. According to the FDA drug safety information, Ozempic, an injection, and Rybelus, a tablet, are currently approved for patients with type 2 diabetes and heart disease to improve glycemic control and reduce the risk of heart attacks, stroke, and death.
While not formally approved for weight loss, many patients have been prescribed Ozempic for off-label weight management. Meanwhile, Wegovy has been approved to help obese and overweight patients with weight-related medical conditions lose and maintain weight loss.
These medications are only effective with concurrent lifestyle changes, including healthy eating habits and regular exercise.
As a result of social media popularity, semaglutide has rapidly become a sought-after drug, leading to subsequent shortages. In fact, patients from the United States traveled to Canada to obtain the medication in less expensive forms, with prices being more than 50% less expensive. British Columbia, a Canadian Province, banned the drug’s sale to US citizens to prevent domestic shortages.
With domestic shortages in the US starting in May 2023, compounders have developed compounded versions of the drug to deliver the appropriate care to patients. Drug compounding involves tailoring medications to a patient’s need by mixing two or more existing drugs.
According to the FDA, “When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act.”
The organization hypothesizes that adverse events reported by patients on semaglutide were due to salt formulations that have not been proven safe and effective.
The FDA concluded, “Healthcare professionals who are considering working with compounders to obtain semaglutide products should be aware that compounders may be using salt forms of semaglutide. FDA is not aware of any basis for compounding a drug using semaglutide salts that would meet federal requirements.”
