Patients dissatisfied with approved weight-loss drugs are turning to the gray market to buy retatrutide, an Eli Lilly medication that is not yet approved by the US Food and Drug Administration (FDA) and is still being studied in clinical trials.
Henry, a thirtysomething living in the Pacific north-west who asked that his last name not be used, started taking Ozempic about two years ago after experiencing hypertension, sleep apnea and body image issues. Although he lost weight, he suffered constipation, a common side-effect, and wanted to try retatrutide, a peptide that targets GLP-1 and two other hormone receptors. He read about the drug in the news and on Reddit forums, then bought it online from sellers in China.
Doctors warn against self-prescribing
Physicians see retatrutide as a promising potential solution for people struggling with obesity but strongly warn patients that using it without oversight from doctors and government regulators seriously risks their health.
“All of these medications should be monitored and prescribed in a medical situation where the doctor or the clinic is partnering with the patient on a complete plan” including “monitoring their lab [work], their vital signs, their response”, said Dr David Shafer, a plastic surgeon in New York who takes the drug. “It’s really the self-prescribing and unknown usage that is leading to a lot of the problems.”
Retatrutide is a “triple agonist”, meaning it targets the GLP-1 and GIP receptors as well as glucagon, which speeds up the body’s metabolism and helps it break down fat cells for energy. In an 80-week clinical trial, patients with severe obesity and heart disease taking the highest weekly doses achieved an average weight loss of 22%, or 55lb, according to Eli Lilly.
High demand and limited access
“The more natural gut hormones that you upregulate, the more weight loss we see,” said Dr Caroline Messer, an endocrinologist in New York. If a patient asked whether she recommends the drug, she said: “Wholeheartedly – but not through the gray market. Just wait till it hits the market.”
Messer said patients ask her about retatrutide about five times daily. Most of them “have maxed out on Zepbound and still are not at their target weight, but it’s also people who enjoy being at the cutting edge of things”. A Reddit group dedicated to the drug gets more than 179,000 visits each week.
In August, Eli Lilly announced it would provide a limited number of patients access to the drug before the FDA approves it, Reuters reported. But Messer said the process is “just so unbelievably difficult” to qualify for special access that it could take years, by which time the FDA will likely have already approved it. “It pits the patient against the doctor because now the patient thinks that we are not doing everything we can to get them the medication, where it’s really actually just this super-onerous process,” she said.
Risks and legal actions
The Reddit group features a “beginner’s guide” to getting the drug through the gray market, with instructions on dosing and a warning not to use the product if it comes in a prefilled pen. Eli Lilly recently filed lawsuits against six companies that allegedly sold the drug, including Lone Star Peptide, based in Texas, and Aesthetic Envy Cosmetic Centers, a med-spa in Sacramento, California. A person who answered the phone at Lone Star Peptide declined to comment; Aesthetic Envy did not respond to a request.
“Illegal drugs made outside of a regulated, inspected supply chain are more likely to contain bacteria and other harmful contaminants and impurities. Consumers have no way to know whether these products are safe or effective,” a lawsuit states. In June, the Victoria state government in Australia reported six cases of acute liver toxicity among patients who consumed a product labeled as retatrutide.
Despite warnings, patients are still buying the drug on the gray market and at least sometimes getting their desired results. “The ones who have plateaued on tirzepatide [Zepbound] are starting to lose weight again, so losing an additional 20 to 30lb,” Messer said.
Henry has not told his doctor he is taking retatrutide because he did not want documentation of it, he said. He has lost 30lb since starting on it and is “doing good”, even though his skin has become extra sensitive, a common side-effect. “For the first time in my entire life, I feel like I am in control of my body,” said Henry, who also now drinks less alcohol.
Shafer said that even if people are not obtaining retatrutide from a prescription, they should disclose their use of it to their provider. “The doctors are not the police, and they are not going to turn you in for buying something online,” he said. “The doctor and the patient can partner together to formulate the best plan.”
Shafer started taking a GLP-1 agonist to lose about 20lb for health and aesthetic reasons, then began taking retatrutide after his weight loss plateaued and because he expected to someday prescribe it to patients. He obtained it from a compounding pharmacy and said it helped him lose weight, improved his muscle tone and reduced his blood pressure. He argues that the FDA should expedite its review of the drug. “I don’t think it’s something that should take 10 years for them to do studies on,” Shafer said. “Then you’re going to have all these other people that are doing it anyway off the black market, and who knows what it is they are taking.”
