FDA sent warning letters to six companies selling compounded retatrutide
https://www.medpagetoday.com/popmedicine/cultureclinic/117942
The FDA has warned six online companies for selling compounded retatrutide, an unlicensed weight-loss drug that has gained traction among social media influencers.
U.S. firms and one in Germany received similarly worded letters in September
for selling products labeled as retatrutide, a compound developed by Eli Lilly that is still in clinical testing, without FDA authorization.
The agency said
the companies violated federal law by marketing the unapproved drug and misbranding products that require medical supervision but lacked adequate directions for safe public use. The compound does not qualify for compounding exemptions.
“Retatrutide is an investigational molecule that is legally available only to participants in Lilly’s clinical trials,” a company spokesperson told MedPage Today in an email. “Anyone purporting to sell retatrutide for human use is breaking the law, and no one should consider taking anything claiming to be retatrutide outside of a Lilly-sponsored clinical trial.”
The warnings come amid surging online interest in retatrutide. An investigation by the Guardian
found fitness influencers and sellers on platforms such as WhatsApp and Telegram driving demand for the compound, which they promote for its purported fat-burning properties.
“The GLP-1 boom has sort of taken over social media,” Daniel Rosen, MD, a bariatric surgeon in New York City with a large Instagram following
, told MedPage Today. “You have this idea of people treating themselves. You have a boom of new players on the scene looking to cash in.”
“So all of a sudden, you have pharmacies marketing directly to patients. You have coaches or content creators who are moving into the space of wellness and having brand deals with laboratories that are producing these drugs for experimental uses — but that’s wink-wink in terms of, the package says ‘not for human consumption,'” Rosen added. “That’s the kind of stuff that you’ll see.”
Retatrutide, a triple-hormone receptor agonist, targets glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide 1 (GLP-1), and glucagon receptors. Phase II data
have shown strong results: participants receiving the highest dose lost an average of nearly a quarter of their body weight within a year, and all in that group lost at least 5%.
“The issue is, that’s phase II,” Stuart Weinerman, MD, an endocrinologist at Northwell Health in Great Neck, New York, told MedPage Today. “No one should use drugs that are not yet proven to be safe and effective until they are out on the market, FDA approved. We don’t know the final data. There can be surprises in phase III trials that did not show up in the preliminary data.”
Still, those early results have fueled viral interest. The Guardian cited several TikTok users promoting the drug, including one who offered a discount code and others who invited users to message privately for purchasing advice.
“I am concerned about influencers promoting this medication before FDA approval,” Noor Khan, MD, a bariatric medicine specialist at the University of Pittsburgh Medical Center, told MedPage Today in an email. “This can lead to use of counterfeit or contaminated medications and can lead to adverse health outcomes, especially if patients are not being monitored for appropriate use. These are powerful medications and need to be used responsibly.”
The viral buzz surrounding retatrutide has led curious patients to question their physicians about it.
Weinerman said the barrage of inquiries he has fielded reflects “a very broad range of opinions partly seeded by nonsense on social media,” from questions about cost and availability to distrust of drugmakers.
Rosen warned that physicians who prescribe medicine without FDA approval are “exposing yourself to liability.”
“From a safe-practice standpoint, it’s better to wait and know all the data and be able to present that to patients to make informed decisions,” Rosen added. “I think it’s better to lose market share on the Reddit craze and be conservative from that perspective. That’s how I’m approaching it.”
Patients who buy retatrutide online, experts said, have no assurance of what’s in the vial: it could be counterfeit, incorrectly dosed, or simply the wrong drug for their needs.
“They may not be appropriate candidates for this medication because of their other health issues, and lack of medical oversight can lead to serious adverse outcomes,” Khan said.
The FDA letters require written responses within 15 working days. As of mid-October, however, the agency’s website showed no record of any replies. Five of the six companies continued to sell retatrutide, with prices ranging from $99.99 for a single 10-mL vial to $1,025 for a 3-month supply.
“It could be cheap,” Weinerman cautioned, “but it still could be poison.”
MedPage Today contacted the FDA, the six companies for comment but did not receive responses by press time.
Filed under: General Problems
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