FDA Reviews Two Death Reports Linked to Unapproved Retatrutide

Two people have died after taking unauthorized products marketed as retatrutide, an experimental weight-loss drug developed by Eli Lilly, according to adverse-event reports received by the U.S. Food and Drug Administration in July and September. The reports raise concerns about unregulated access to the drug, although investigators have not established whether the products caused or contributed to either death.

Documents reviewed by CBS News indicate that one case involved a 41-year-old woman who suffered cardiac arrest, while the other concerned a 49-year-old patient who experienced severe dehydration, malnutrition and cardiac arrest. Both reports were submitted to the FDA's Adverse Event Reporting System, which helps the agency monitor medication safety.

The FDA has not confirmed the details of either case. CBS News obtained the documents through a Freedom of Information Act request, but the agency redacted identifying information, preventing independent verification of the reported circumstances.

In the July report, a healthcare professional identified retatrutide as a "suspect product" and said the woman had obtained it "from an unreliable source." The patient was taken to a hospital with an extremely rapid heartbeat and died after resuscitation attempts failed.

The report described her as someone with a history of obesity who "appears to be otherwise healthy adult female." It also noted that she was consuming kava, a plant-based drink associated with relaxing effects, when the medical emergency occurred.

The September report described a separate case involving a 49-year-old patient who obtained retatrutide after a registered nurse "convinced" her to purchase the product from an online peptide vendor. According to the report, the nurse "provided her the link and sold her vials and provided recommended dosages."

The document identified a vial bearing the name "AlphaLabs" and a website advertising peptides for "research use only." CBS News reported that company owner Joseph Samara had filed a trademark application for Alpha Labs earlier in the year, with submitted materials listing retatrutide among the products offered.

When approached by CBS News, Samara initially responded, "we don't sell retatrutide" and "you have the wrong Alpha Labs," before ending the call. The source material provided for this report ends before the subsequent response from Sinead Killeen, an attorney representing Samara.

Harvard Medical School associate professor Pieter Cohen said the cases raised concerns about the regulatory process governing medications in the United States.

"It is concerning because of the breakdown of our drug-approval process in the United States of America," Cohen said.

Cohen also called for laboratory testing of the products involved in the deaths to determine what the patients had received.

"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.

He further questioned whether the agency was adequately investigating the cases.

"If the FDA is not aggressively investigating these cases, that's deeply concerning," Cohen said.

The FDA said it reviews adverse-event reports and seeks additional information when necessary, while declining to discuss whether it had verified either death report.

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

Eli Lilly said the reported deaths involved unauthorized products rather than medication supplied through its clinical trials.

"make clear the two individuals were taking black-market retatrutide," the company said in a statement about the reports.

The company said it had identified suspect products containing excessive amounts, insufficient amounts or incorrect active ingredients, as well as contaminants that could endanger users.

"with too much, too little, or the wrong active ingredient," Eli Lilly said, describing the composition of suspect products. The company warned that contaminants "can put patients at serious risk."

Eli Lilly is pursuing legal action against companies selling unauthorized versions, arguing that adverse reactions involving those products could damage public confidence in its future medicines.

The company described the potential reputational harm as "poisoning the well for the future of retatrutide medicines."

Retatrutide remains investigational and has not been approved by the FDA. Federal law prohibits the commercial sale of unapproved drugs, but unauthorized products have continued to appear online and through other sellers.

America's Poison Centers has recorded a sharp increase in reported retatrutide exposures since it began tracking them late last year. The nonprofit logged 862 exposures during the three months ending in September, compared with 460 in the preceding three months and 249 during the first three months of 2026.

Clinical trials have shown substantial weight-loss potential for retatrutide, generating interest among patients and investors. In a July news release, Eli Lilly said serious heart-related reactions "occurred less frequently than anticipated" among participants receiving retatrutide and those receiving a placebo, while the drug reduced certain measures of cardiovascular risk.

The two reported deaths were not associated with formal clinical trials, according to the documents and Eli Lilly. The cases highlight unresolved questions about the safety and composition of products sold outside the regulated research process.