May 31, 2023 – The FDA warns against using compounded drugs as substitutes for popular weight reduction and diabetes drugs Ozempic, Rybelsus and Wegovy.
Compounded drugs should not approved by the FDA, but are allowed to be manufactured during an official drug shortage. Ozempic and Wegovy are currently on the FDA's list of medicine that may not be manufactured, however the federal agency warned Tuesday that it has received reports of individuals experiencing “adverse events” after taking compounded versions of the drugs. (The FDA didn't provide details about those events or where the drugs in query were compounded.)
Agency officials fear that the compounded versions may contain ingredients that sound just like the brand-name drug's energetic ingredient, semaglutide, but differ in that the ingredients are in salt form.
“Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be saline formulations that FDA warning stated: “Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.”
The agency stated that salt forms didn't meet the factors for manufacturing compounded products during a shortage and sent a letter to the National Association of Boards of Pharmacy expressing “concerns about the use of the salt forms in compounded products.”
Patients and healthcare professionals must be aware that “compounded drugs are not approved by the FDA, and the agency does not review the safety or effectiveness of compounded drugs,” the FDA said in its statement.
The Alliance for Pharmacy MixturesThe board of directors said in an announcement that the arguments made by some compounders for the suitability of semaglutide sodium were “worthy of discussion,” however the board didn't support those arguments.
For people using a web-based pharmacy, the FDA recommends checking the FDA website BeSafeRx to confirm his credentials.