FDA chief sounds alarm over sale of fake weight loss drugs circulating online

GLP-1 agonist drugs are having their moment in the spotlight, but shortages brought on by increased demand are compelling some users to look for quick alternatives that have U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert Califf a bit concerned.

Compounded versions of the drugs – which combine a medication with other ingredients thought to be safe for use – are sold "without proper controls to ensure they [consumers] get the right active drug," Califf told Reuters, but counterfeit versions of the products pose another problem.

"In the context of the total picture of illicit drugs being sold on the internet, it's almost certainly… much bigger than what we see," he said.

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The World Health Organization, according to the outlet, offered similar takes on the concerning uptick, saying the so-called drugs could potentially cause a toxic reaction due to being created in contaminated conditions.

They also likely lack efficacy.

Novo Nordisk's Ozempic, a semaglutide drug approved to treat type 2 diabetes, is additionally sold under the "Wegovy" label since being approved as an obesity treatment. 

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Eli Lilly's Mounjaro, the first-in-class GLP-1 and GIP agonist combination (tirzepatide) drug for type 2 diabetes, saw a similar relabeling after being approved for obesity treatment late last year. It is now additionally sold under the label "Zepbound."

The injectables, which suppress appetite and help the body respond to the insulin hormone more efficiently, are also occasionally prescribed off-label to help treat other endocrinological conditions that commonly involve the hormone or the body's resistance to it, including prediabetes, polycystic ovarian syndrome (PCOS), insulin resistance and metabolic syndrome.

According to clinical trials, these injectables have helped patients lose 15% to 20% of their body weight.

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Each drug has experienced longstanding shortages as demand has surpassed supplies, fueling the illicit market in addition to lining the pockets of compounding pharmacies.

According to Reuters report, the FDA sent warning letters to two online vendors for selling illicit versions of Wegovy and Zepbound earlier this month and fake versions of Ozempic have previously hospitalized some after they suffered from hypoglycemia.

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