FDA Gets Reports of Two Deaths After People Took Bootleg Versions of Experimental Retatrutide

The Food and Drug Administration has 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 the FDA has not approved. Federal law bars the commercial sale of unapproved drugs, but vendors have sold imitation versions online at a scale with no modern precedent. The cases appear to be the first public accounts in the United States alleging that unauthorized use of retatrutide, or of products claiming to contain it, played a role in a patient's death. The details are not verified, and it is unclear whether the drug was to blame.

The first death was reported in July, when a healthcare professional told the FDA that a 41-year-old woman with obesity went into cardiac arrest. The report lists retatrutide as a "suspect product" and says she got it "from an unreliable source." 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. She experienced severe dehydration, malnutrition and cardiac arrest.

The reports alone do not prove the drugs caused or contributed to either death. They do point to the dangers of an illicit market for unapproved drugs. "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."

Earlier CBS News investigations 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 it, and some sellers have been helped by an independent, blue-chip certification that gives them the appearance of legitimacy and lets them advertise on social media.

The reports were filed in the FDA's Adverse Event Reporting System, which is designed to help the agency monitor the safety of drugs it has approved. According to the documents and to Eli Lilly, neither death is connected to a formal clinical trial, even though retatrutide is generally not supposed to be available outside of one. CBS News obtained the documents under the Freedom of Information Act, and the agency redacted details that could identify the people involved. The network said it could not independently verify what the reports say.

The FDA declined to say whether it has verified the information in either report. "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." The two deaths are part of an emerging picture of possible side effects from a drug many people obtain from unregulated sellers with little or no medical supervision.