Beware of off-brand versions of weight loss drugs, the U.S. Food and Drug Administration (FDA) warned this week, cautioning that their ingredients have not been studied for safety or effectiveness.
There is no generic form of Ozempic or Wegovy, which have become popular in recent years as weight-loss tools. Both are primarily anti-diabetes drugs, but their appetite-suppressant side effects have caught the attention of those who want to slim down. This has made the medicines difficult to obtain, especially Ozempic.
While Wegovy is approved to treat obesity as well as to combat insulin resistance, Ozempic and its sibling Rybelsus are only FDA-sanctioned to treat type 2 diabetes. The interest and skyrocketing sales have made Ozempic and Wegovy scarce and landed them on the FDA’s list of drug shortages.
In the absence of generics, pharmacies are legally allowed to produce their own versions in a process called “compounding.” But online vendors are also getting into the act, and many of those formulations may contain salt forms of semaglutide, which are different active ingredients than those used in the approved drugs and have not been greenlit for human use.
“Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality,” the FDA said in its advisory issued Wednesday. “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. Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.”
The FDA added that it has received reports of problems from use of compounded versions of semaglutide, without specifying what the problems were. The agency urged people to get their semaglutide drugs via prescription from a licensed health care provider, from state-licensed pharmacies or from other facilities that are FDA-registered.
State regulators are also onto the rogue compounders, NBC News reported last month. Louisiana, Mississippi, North Carolina and West Virginia officials are aware of the different form being used by some compounding pharmacists, and some have threatened legal action against pharmacies that make or distribute the unauthorized versions.