WEDNESDAY, June 21, 2023 (HealthDay News) -- The maker of three popular drugs that treat weight loss and diabetes said Tuesday that it has begun legal proceedings against businesses that are selling compounded versions of its products that are not approved by the U.S. Food and Drug Administration.
In a statement, the company said it is telling these med spas, weight loss clinics, and compounding pharmacies "to cease and desist from false advertising, trademark infringement, and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide."
Novo Nordisk makes the weight loss drug Wegovy and the diabetes drugs Ozempic and Rybelsus, and semaglutide is the key ingredient in those medications.
"These unlawful marketing and sales practices … have created a high risk of consumer confusion and deception as well as potential safety concerns," Novo Nordisk said. "Compounded products do not have the same safety, quality, and effectiveness assurances as our FDA-approved drugs and may expose patients to health risks. Novo Nordisk cannot validate the safety or effectiveness of products claiming to contain semaglutide that are not one of our own branded products. Novo Nordisk is the only company in the U.S. with FDA-approved products containing semaglutide, and no FDA-approved generic versions of semaglutide currently exist."
In May, the FDA also warned customers about these alternate products and the compounding of these medications, noting that people have reported adverse events and that patients "should not use a compounded drug if an approved drug is available."
But two of the Novo Nordisk drugs, Ozempic and Wegovy, have been in short supply since last year. "When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements of the Federal Food, Drug, and Cosmetic Act," the FDA said in its warning, but the drugs are not reviewed for quality or safety. The compounded versions of semaglutide may be using salt forms, such as semaglutide sodium and semaglutide acetate, with different active ingredients than those approved by the FDA.