Agency does not review compounded drugs for safety, effectiveness, or quality; compounded medications are not FDA-approved
By Physician’s Briefing Staff HealthDay Reporter
WEDNESDAY, May 31, 2023 (HealthDay News) — Patients taking semaglutide for type 2 diabetes or weight loss should be careful about where they are getting the medication, the U.S. Food and Drug Administration warned Tuesday. Shortages of the drug, commonly sold as Wegovy and Ozempic, have led to the making of compounded versions of the drugs, which is combining or mixing ingredients to meet patient needs.
Compounders can make a version of a drug if the medication is in shortage and they meet requirements of the Federal Food, Drug and Cosmetic Act. But the FDA said it has received reports that some patients have had some problems after taking the compounded drugs. The agency warned that patients should not use a compounded drug if an approved drug is available. Patients and their doctors should also understand that the FDA does not review compounded drugs for safety, effectiveness, or quality. Compounded medications are not FDA-approved.
Among the issues are reports that compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients from those used in the approved drugs. The agency said it has expressed concern to the National Association of Boards of Pharmacy about the use of salt forms of semaglutide in these products.
Patients intending to use semaglutide should have a prescription from a licensed health care provider and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with the FDA, the agency said.
If buying from unregulated and unlicensed sources, patients should know they may be exposed to potentially unsafe products, the FDA cautioned. Health care providers should also be aware that compounders may be using salt forms of semaglutide, the FDA noted.
Three FDA-approved semaglutide products are sold in the marketplace. These include Ozempic and Rybelsus, which are approved for lowering blood sugar levels in those with type 2 diabetes. Ozempic can also be used to lower the risk for heart attack, stroke, or death in adults with type 2 diabetes and heart disease. Wegovy is approved to help people with overweight and obesity and at least one weight-related medical condition lose weight.
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