Is a bootleg weight-loss drug to blame for 2 reported deaths?

The Food and Drug Administration received reports in recent months that two people died after taking bootleg versions of an experimental weight-loss drug, according to documents reviewed by CBS News.

The reports link the deaths to products claiming to be retatrutide, a drug being developed by Eli Lilly that hasn't been approved by the FDA. Federal law prohibits the commercial sale of unapproved drugs, but that hasn't stopped vendors from selling imitation versions of the experimental drug online at a scale with no modern precedent. 

The cases appear to be the first public accounts in the U.S. alleging that unauthorized use of retatrutide — or products claiming to contain it — played a role in a patient's death, though the details aren't verified and it is unclear whether the drug was to blame.

The first death reportedly occurred in July, when a healthcare professional informed the FDA that a 41-year-old woman with obesity went into cardiac arrest. The report lists retatrutide as a "suspect product," noting the woman had obtained it "from an unreliable source." 

Then in September, the FDA received a report that a 49-year-old patient died after a licensed nurse "convinced" her to buy retatrutide from an online peptide vendor and she experienced severe dehydration, malnutrition and cardiac arrest.

Though the reports alone don't prove that the drugs caused or contributed to patient deaths, they point to the potential dangers of an illicit market for unapproved drugs like retatrutide.

"It is concerning because of the breakdown of our drug-approval process in the United States of America," said Pieter Cohen, an associate professor at Harvard Medical School. 

"The FDA should do whatever it possibly could do to get their hands on the actual drug that was injected by both of these patients, and they should get that analyzed," he said. "If the FDA is not aggressively investigating these cases, that's deeply concerning."

Previous investigations by CBS News have found the drug widely available in health spas, on wellness websites and even in some convenience stores. Dozens of medical professionals have openly promoted access to retatrutide, and some sellers have been aided by an independent, blue-chip certification that gives them the appearance of legitimacy and the ability to advertise it on social media.

The reported deaths were submitted to the FDA's Adverse Event Reporting System, which is designed to help the agency monitor the safety of drugs it has approved. The two reported deaths aren't connected to a formal clinical trial, according to the documents and Eli Lilly, even though retatrutide is generally not supposed to be available outside of one. 

The FDA declined to say whether it has verified any of the information in either reported death. 

"We review adverse event reports, gathering additional information when needed," the agency said in a statement, adding that it "generally does not discuss potential or ongoing compliance matters." 

CBS News was not able to independently verify the information included in the reports, which were obtained under the U.S. Freedom of Information Act and redacted by the agency to remove details that could identify the people mentioned in them. They are part of an emerging picture of potential side effects from a drug that many people are obtaining from unregulated sellers and with minimal to no medical supervision.

America's Poison Centers, a nonprofit, has tallied a steady increase in reported exposures to retatrutide since it began tracking them late last year, which is common for a newly monitored drug. The centers logged 862 exposures to retatrutide in the three months ending in September, up from 460 in the three months prior and 249 in the first three months of 2026.

In clinical trials, retatrutide has been shown to help people lose even more weight than the most effective weight-loss drugs on the market, kindling excitement about its potential and fueling Wall Street's expectations that it will be a blockbuster. In a July news release, Eli Lilly said serious heart-related reactions "occurred less frequently than anticipated" in patients who received retatrutide as well as those who got a placebo, while the drug reduced certain measures of cardiovascular risk.

"Black-market retatrutide"

In a statement, Eli Lilly said that the reported deaths "make clear the two individuals were taking black-market retatrutide." The company said it has found suspect products "with too much, too little, or the wrong active ingredient," along with contaminants that "can put patients at serious risk."

Eli Lilly is taking legal action against companies selling bootleg versions of retatrutide, claiming that people will associate bad reactions to them with its product, "poisoning the well for the future of retatrutide medicines." 

The first death reported to the FDA, in July, said the 41-year-old woman was taken to a hospital with a dangerously fast heart beat and died after multiple approaches to resuscitate her failed. The healthcare professional who filed the report said the patient had a history of obesity but "appears to be otherwise healthy adult female." The report also said the patient was drinking kava — an apparent reference to a plant-based drink known for its relaxing properties — at the time of the emergency.

The second death report, in September, said a 49-year-old patient purchased retatrutide after a registered nurse — whose name, location and license number were redacted by the FDA — "provided her the link and sold her vials and provided recommended dosages." The report did, however, name a source for the drug.

An image in the report shows a vial with the name "AlphaLabs" and a website, which offers peptides for "research use only." The company owner, Joseph Samara, applied for a trademark for the name Alpha Labs earlier this year, including screenshots listing its offerings that included retatrutide.

When contacted by a CBS News reporter, Samara initially said "we don't sell retatrutide" and that "you have the wrong Alpha Labs" before hanging up. Sinead Killeen, an attorney representing Samara, later said in a statement that her client "had no means of verifying the caller's identity or credentials, did not believe he was speaking with a member of the press, and declined to engage."

Killeen said there simply wasn't enough information in the redacted report to the FDA to know if Alpha Labs sold the product or if it came from another vendor — no batch or lot number to check against its records, no visible names to determine if the patient or nurse were customers. The image of the vial included in the report "does not match the company's current packaging," she said.

"We extend our sympathies to the family of the individual described in the report," Killeen wrote.

The attorney expressed concern over the nurse's role as described in the report. "A licensed healthcare professional should never recommend research-use-only products to a patient, provide dosing instructions for them, administer them, or sell them," she wrote.

Killeen said the company would support a review from the authority that licensed the nurse. She said Alpha Labs had not been contacted by the FDA.