WASHINGTON — The FDA has received two adverse-event reports describing deaths of people who took bootleg products sold online as "Reta" — retatrutide, an experimental, still-unapproved weight-loss drug Eli Lilly is developing — according to redacted federal records obtained by CBS News through a Freedom of Information Act request. Neither the FDA nor CBS could independently confirm the drug caused either death.

In the first case, reported in July, a 41-year-old woman with obesity went into cardiac arrest; a healthcare professional's report lists retatrutide as a "suspect product" she'd obtained "from an unreliable source." She had reportedly been drinking kava, and resuscitation attempts failed. In the second, reported in September, a 49-year-old patient died after severe dehydration, malnutrition and cardiac arrest. The report alleges a licensed nurse, whose identity is redacted, persuaded the patient to buy retatrutide from an online peptide vendor called AlphaLabs, sold her the vials and gave dosing advice.

A vendor denies, and calls surge

AlphaLabs' listed owner, Joseph Samara, told a CBS reporter "we don't sell retatrutide" before hanging up, according to the outlet. His attorney, Sinead Killeen, said the adverse-event report lacks batch or lot numbers, that the vial photo doesn't match the company's current packaging, and that the FDA has not contacted the company. She added that "a licensed healthcare professional should never recommend research-use-only products to a patient, provide dosing instructions for them, administer them, or sell them."

"IT IS CONCERNING BECAUSE OF THE BREAKDOWN OF OUR DRUG-APPROVAL PROCESS."

The cases surface as demand for black-market GLP-1-style peptides has exploded. America's Poison Centers logged 862 retatrutide exposure calls in the three months ending in September — up from 460 the prior quarter and just 249 in the first quarter of the year. Eli Lilly, which has sued several companies it says sell unauthorized or contaminated versions of the drug, said in a statement that the two deaths "make clear the two individuals were taking black-market retatrutide." The FDA said it "generally does not discuss potential or ongoing compliance matters," but reviews adverse-event reports, "gathering additional information when needed."

Pieter Cohen, an associate professor at Harvard Medical School who studies supplement safety, called it "deeply concerning" if the FDA isn't aggressively investigating, adding that "it is concerning because of the breakdown of our drug-approval process in the United States of America." He said regulators should obtain and analyze the actual products the two patients had injected. Retatrutide remains in late-stage clinical trials and has not been approved for any use in the U.S.