Nobody Has Approved This Weight-Loss Drug. Two People May Have Died Buying It Anyway.
Documents reviewed by CBS News show the Food and Drug Administration received at least two reports this year of people dying after taking products sold as retatrutide, an experimental Eli Lilly obesity drug that no regulator anywhere has approved. One was logged by a healthcare professional in July: a 41-year-old woman with obesity went into cardiac arrest after taking retatrutide from what the report describes as an "unreliable source," and the drug is listed as a "suspect product." The second arrived in September: a 49-year-old patient died after severe dehydration, malnutrition and cardiac arrest. She had bought the product from an online peptide vendor, reportedly on the recommendation of a licensed nurse. An image filed with one report shows a vial labeled "AlphaLabs," sold on a site that offers peptides for "research use only." Whether the drug actually caused either death has not been established, and the accounts have not been independently verified.
Eli Lilly said in a statement that the two deaths "make clear the two individuals were taking black-market retatrutide." The company says it has found suspect products containing "too much, too little, or the wrong active ingredient," along with contaminants that "can put patients at serious risk." Chief medical officer David A. Hyman put it bluntly: "What is being sold on the black market is not a medicine — it is entirely unverified, unapproved and not worth the risk."
America's Poison Centers, a nonprofit that began tracking retatrutide exposures late last year, logged 862 exposures in the three months ending in September, up from 460 in the prior three months and 249 in the first quarter of 2026. Poison center figures computed for the first four months of 2026 were up roughly 265% compared with the last four months of 2025. Exposure reports are not counts of confirmed poisonings or deaths.
On Sept. 29, Lilly released full phase 3 TRIUMPH-2 results at the EASD meeting in Milan and published them in The Lancet. Among 1,152 adults with obesity and type 2 diabetes, the 12 mg dose produced an average 20.8% (49.6 lbs) weight loss over 80 weeks; participants starting with a BMI of 35 or higher lost an average of 23.4% (60.8 lbs), and more than half no longer met the BMI criteria for obesity. In a separate 2,339-person obesity trial, the top dose cut body weight 25.0% over 80 weeks against 3.9% for placebo. No injectable obesity drug has come close to that.
Gastrointestinal complaints — diarrhea, nausea, constipation, vomiting — were the most frequent side effects, which Lilly characterized as mild to moderate. A less familiar signal is dysesthesia, an altered or tingling skin sensation: it reached 20.9% on the 12 mg dose in TRIUMPH-4 versus 0.7% on placebo. Heart rate rose with dose, peaking around week 24 and declining afterward. In TRIUMPH-2, 7.7% of patients on the highest dose stopped treatment because of adverse events, versus 4.9% on placebo.
Australia's Therapeutic Goods Administration warned on Sept. 14 that a consumer suffered uncontrollable vomiting and a torn oesophagus requiring hospital treatment after using a product sold as retatrutide — an injury the regulator calls almost universally fatal without prompt care. Laboratory testing of the unmarked vial found no retatrutide at all. Instead it contained undeclared semaglutide, the active ingredient in Ozempic and Wegovy, at roughly eight times the concentration of TGA-assessed semaglutide products.
Lilly says it has reported more than 14,000 websites, ads, social media posts and product listings for the drug across more than 100 countries to internet service providers and e-commerce platforms, and referred more than 200 individuals and entities to the FDA, the Department of Justice and other regulators. On Aug. 12 it filed six federal lawsuits targeting four "research use only" peptide vendors, a California med spa (Aesthetic Envy Cosmetic Centers) and a Texas compounding pharmacy (Striker Pharmacy). In October it added five more suits, naming American Peptides, LiveWell Peptides, Cenexa Labs, Medrein Health & Aesthetics and Medshape Weight Loss Clinic. Lilly argues the copycats are "poisoning the well for the future of retatrutide medicines."
Earlier CBS News investigations found retatrutide being sold through health spas, wellness websites, telehealth companies, medical clinics and even Brooklyn bodegas; a June investigation identified more than 120 websites selling or promoting it, including more than 50 clinics staffed by licensed medical professionals. Several vendors display LegitScript certification, a seal meant to signal regulatory compliance, which the certifier's own rules prohibit for an unapproved drug. Federal law bars the commercial sale of unapproved drugs.
Lilly has said it plans to submit a Biologics License Application to the FDA in the first quarter of 2027, a delay from its earlier end-of-2026 target, to complete manufacturing and quality-control data. Under a standard review, prescription availability would point to late 2027 or 2028. For now the only legal routes are clinical trials and a narrow, single-patient expanded access program (NCT07629401). Pieter Cohen, an associate professor at Harvard Medical School, told Gizmodo the situation is concerning "because of the breakdown of our drug-approval process in the United States of America."