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A costly jab.
As more information is coming to light about one of the newest’s weight loss drug, the FDA’s Adverse Event Reporting System received reports of two deaths from bootleg versions of the medication.
The products claimed to be the super-effective drug that’s nearing the end of clinical trials but has yet to be approved by the agency, making the deaths appear to be the first public accounts of unauthorized use in the US.
While the commercial sale of unapproved drugs is prohibited, more are clamoring to get their hands on retatrutide — nicknamed “reta” — even before it’s legal, inspiring copycats of the unapproved drug on the gray peptide market.
The first death, which occurred in July, involved a 41-year-old woman with obesity who suffered cardiac arrest. According to an FDA report from a healthcare professional that listed retatrutide as a “suspect product,” the woman had obtained the medication “from an unreliable source.”
The agency received a second report in September of a 49-year-old patient who died after a licensed nurse “convinced” her to purchase the drug from an online peptide vendor. The victim experienced severe dehydration, malnutrition and cardiac arrest.
An image from the report shows the medication appeared to be from a company called “AlphaLabs,” which offers peptides for “research use only,” according to screenshots from their website.
“We review adverse event reports, gathering additional information when needed,” the FDA said in a statement, adding that it “generally does not discuss potential or ongoing compliance matters.”
While the reports don’t prove the newest weight loss medication was the cause of either death, they highlight potential dangers of obtaining an unapproved drug off an illicit market.
“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,” associate professor at Harvard Medical School Pieter Cohen told CBS News.
“If the FDA is not aggressively investigating these cases, that’s deeply concerning.”
According to Public Citizen, at least 14 people have been hospitalized after taking gray-market versions of retatrutide.
In a July news release, the developer of the drug, 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.
The statement also reported the drug reduced certain measures of cardiovascular risk.
Previous investigations have found the experimental drug casually sold on wellness websites, at health spas and even in Brooklyn bodegas, although independent labs failed to identify any retatrutide in the medications.
The first of its kind to target three metabolic receptors (GLP-1, GIP and glucagon), retarutide has been shown to produce dramatically greater weight loss than blockbuster drugs like Ozempic and Mounjaro.
Researchers reported back in May that users lost up to 28% of their body weight over 80 weeks, or about a year and a half.
Its effectiveness has garnered fans from menopausal moms to looksmaxxing teens, with Lilly even trying to tamp down knockoffs with a flurry of lawsuits.
While the company plans to submit retatrutide for FDA approval in early 2027, the FDA’s review process could take up to a year before the drug hits the market, if approved.