(NewsNation) – An increasing flood of compounded GLP-1 weight-loss medications on the market has led to cautionary advisories from medical professionals and the U.S. Food and Drug Administration.
Recently, the FDA dispatched 25 warning notices to telehealth businesses, criticizing them for allegedly making deceptive claims regarding compounded GLP-1 drugs.
Compounded drugs are custom-made medications where ingredients are modified for individual patients. This specialized approach might replicate over-the-counter drugs, tweaking elements like taste, potency, or the method of delivery. However, unlike drugs that have FDA approval, these compounded options might not meet the established safety, efficacy, or manufacturing reliability standards.
Authorities warn that compounded semaglutide could trigger similar adverse effects as popular brands like Ozempic and Wegovy. Nonetheless, the absence of FDA regulation might further jeopardize patients’ health with additional safety and effectiveness issues.
“People ask me all the time whether these compounded drugs are an option because of the cost and access,” said Dr. Michael Blyumin, Stanford Medicine. “But I advise against it; there are a lot of potential problems that they pose.”
Compounded GLP-1 drugs have grown in popularity largely because they can cost less than brand-name medications and became widely available during shortages of FDA-approved products.
At list price, FDA-approved GLP-1 drugs can cost more than $1,000 per month. Patent protections are expected to prevent generic versions of semaglutide from becoming available in the United States until at least 2032.
“I think people just assume they can’t afford these medications, but there are options they may not know about,” Blyumin said.
The FDA says compounded drugs should generally be used only when a patient’s medical needs cannot be met by an FDA-approved medication. The agency advises patients to obtain prescriptions from their doctors and have them filled by state-licensed pharmacies.
Two years ago, nearly one-third of Americans taking a GLP-1 drug said they obtained it from a compounding pharmacy.