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(NewsNation) — The growing availability of compounded GLP-1 weight-loss drugs has prompted warnings from doctors and the U.S. Food and Drug Administration.
Last month, the FDA issued 25 warning letters to telehealth companies over what it called false or misleading claims about compounded GLP-1 medications.
Unlike FDA-approved drugs, compounded versions have not been proven to be safe, effective or consistently manufactured. Some may contain additional ingredients or alternative forms of the active drug.
Experts say compounded semaglutide can cause many of the same side effects as brand-name medications such as Ozempic and Wegovy. However, the lack of FDA oversight may expose patients to additional safety and effectiveness concerns.
“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.
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