May 31, 2023 – The FDA is warning people to avoid using compounded medicines as substitutes for the popular weight loss and diabetes drugs Ozempic, Rybelsus, and Wegovy.
Compounded medicines are not FDA-approved but are allowed to be made during an official drug shortage. Ozempic and Wegovy are currently on the FDA’s shortage list, but the federal agency warned on Tuesday that it has received reports of people experiencing “adverse events” after using compounded versions of the drugs. (The FDA did not provide details of those events or where the drugs involved were compounded.)
Agency officials are concerned that the compounded versions may contain ingredients that sound like the brand name drugs’ active ingredient, semaglutide, but are different because 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 the salt formulations, the 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 said salt forms don’t meet the criteria for compounding during a shortage and sent a letter to the National Association of Boards of Pharmacy expressing “concerns with use of the salt forms in compounded products.”
Patients and health care providers should be aware that “compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs,” the FDA explained in its statement.
The Alliance for Pharmacy Compounding’s Board of Directors said in a statement that some compounders’ arguments for the suitability of semaglutide sodium are “worthy of discussion,” but the board did not endorse those arguments.
For people who use an online pharmacy, the FDA recommends checking the FDA’s website BeSafeRx to check its credentials.