FDA Halts Compounded Weight Loss Drugs Amid Safety Concerns
The FDA has ordered compounding pharmacies to cease production of compounded versions of popular weight loss drugs like Wegovy and Zepbound, citing resolved shortages of the brand-name medications. This decision raises critical questions about the safety and regulation of compounded drugs, particularly given the rising popularity of GLP-1 medications for weight loss. Eli Lilly, the maker of Zepbound and Mounjaro, and Novo Nordisk, the maker of Ozempic and Wegovy, have both stated they can now meet the demand for their medications, leading the FDA to remove the drugs from its shortage list.
Compounded drugs, unlike FDA-approved medications, do not undergo rigorous premarket review for safety, effectiveness, or quality. The FDA has previously warned consumers about the potential risks associated with using these versions, emphasizing that their compounding program aims to protect patients from poor-quality drugs while preserving access to lawfully marketed compounded drugs. Compound versions of drugs are made for individual patients using raw ingredients and are not required to go through the FDA’s rigorous approval process.
With brand-name drugs like Zepbound and Wegovy now readily available, the FDA is taking steps to ensure patient safety by removing compounded versions from the market. State-licensed compounding pharmacies must immediately stop making compound versions of GLP-1 drugs. Larger outsourcing pharmacies making compound versions of Zepbound have until March 19 to stop, while for Wegovy, these pharmacies have until May 22. Patients currently taking compounded GLP-1 medications should consult their healthcare provider for a prescription for the branded version.
For those concerned about the cost of brand-name GLP-1 medications, ABC News chief medical correspondent Dr. Tara Narula suggests exploring options like manufacturer coupons, often found on drug manufacturers’ websites. Additionally, both Eli Lilly and Novo Nordisk offer consumers who lack insurance coverage the option to buy Zepbound and Wegovy, respectively, on direct-to-consumer platforms at a lower cost.
Zepbound is FDA-approved for weight loss management in individuals with obesity or who are overweight with at least one weight-related condition. It contains tirzepatide, the same active ingredient as Mounjaro, which is FDA-approved to treat Type 2 diabetes. Wegovy contains semaglutide, the same main ingredient as Ozempic, and is FDA-approved for weight loss in people with obesity or who are overweight with at least one weight-related condition. It is also approved to reduce the risk of major cardiovascular events in adults with obesity or who are overweight with established cardiovascular disease. Both tirzepatide and semaglutide work by slowing down the movement of food through the stomach and curbing appetite, thereby causing weight loss.