The agency has received reports of adverse health events in people using compounded versions of the weight loss drugs and expressed concern over incorrect active ingredients in compounded semaglutide products.
On May 30, the FDA issued a postmarket drug safety letter warning people taking Ozempic, Rybelsus tablets, or Wegovy not to use compounded versions of the popular diabetes and weight loss drugs if approved versions are available. All three medications contain the active ingredient semaglutide, which prompts the gastrointestinal system to make insulin and suppresses appetite.
The agency says it has received adverse health event reports from people who used compounded semaglutide. There's also concern that some compounding pharmacies may use salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. These salt forms differ from the base form used in Ozempic, Rybelsus, and Wegovy.
Drug compounding is the process of mixing ingredients to create a medication specifically formulated for a patient. Though compounded medications are not FDA-approved, in a drug shortage situation, compounding pharmacies can sometimes prepare medications to satisfy the demand if they meet specific Federal Food, Drug, and Cosmetic (FD&C) Act requirements.
However, the FDA does not review compounded medications for safety, effectiveness, or quality.
Although Ozempic and Wegovy are currently on the FDA's drug shortage list, the agency is concerned that the salt forms of semaglutide might not meet FD&C requirements and may not be safe and effective.
Therefore, the agency says people should only get Ozempic and Wegovy through their healthcare provider and use a state-licensed pharmacy or an FDA-registered outsourcing facility to fill their prescriptions.
In addition, individuals should use caution when purchasing Ozempic or Wegovy online from unregulated or unlicensed companies. Instead, the agency suggests using BeSafeRx campaign resources to help make online purchasing decisions.
Moreover, if someone experiences an adverse health event taking compounded Ozempic or Wegovy, they should report it to the FDA's MedWatch Adverse Event Reporting program.