Websites selling compounded versions of popular weight-loss drugs frequently omit critical risk information, as revealed by recent research. A study published on Friday highlighted that 79 websites offering these compounded medications from pharmaceutical giants Novo Nordisk and Eli Lilly often fail to inform consumers about associated risks. The study raises concerns about the transparency of these online sellers and the potential implications for consumer safety.
The research uncovered that over half of the 79 websites examined did not disclose the lack of U.S. Food and Drug Administration (FDA) approval for their products. Alarmingly, 37% of the websites misleadingly suggested that their offerings had received FDA endorsement. Moreover, 14% failed to clarify that they were selling compounded products, which are essentially replicas of the original branded drugs, rather than the FDA-approved versions.
The demand for compounded alternatives has surged due to a tight supply of Novo's semaglutide and Lilly's tirzepatide, both popular GLP-1 medications. These compounded versions, however, remain unapproved by the FDA, meaning there is no official verification of their efficacy or safety.
"I'm very worried about the internet compounding industry. Some of it, I'm sure, is very high quality, but it's very hard, if you are ordering things on the internet, to know exactly what you're getting," said outgoing FDA Commissioner Robert Califf.
Furthermore, the study observed that nearly half of the websites did not inform consumers about potential side effects, warnings, or necessary precautions related to the drugs. About 40% exaggerated the benefits of these medications, potentially misleading consumers seeking effective weight-loss solutions.
The cost of these compounded drugs also poses a significant concern. The median first-month prices, inclusive of discounts, ranged from $231 to $330. In comparison, those without insurance coverage would pay $549 for Zepbound through Lilly's pharmacy and $650 for Wegovy with a discount card from Novo.
"The lack of FDA approval means there's no verification of efficacy, no verification of safety," emphasized Ashwin Chetty from Yale University School of Medicine.
Direct-to-consumer advertising of compounded weight-loss drugs is not illegal. However, it undermines U.S. health regulators' efforts to ensure patients have access to safe medications. U.S. laws permit compounding pharmacies to produce these versions during shortages of branded drugs, yet the intent was never to create opportunities for vendors to exploit such shortages.
"Compounding laws 'were not intended to create a window of time where opportunistic vendors exploit a shortage to gain market share and drive new demand through aggressive marketing tactics,'" asserted T. Joseph Mattingly of the University of Utah College of Pharmacy.
To conduct this study, researchers utilized Google Shopping to identify businesses advertising both branded and generic forms of GLP-1 medications between July and September 2024.
"Advertisements for compounded products should be held to the same standards as those of prescription drugs," Mattingly added.
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