Counterfeit versions of Eli Lilly’s retatrutide, hailed as a potential “new Ozempic,” are being sold directly to U.S. consumers via Chinese websites despite being years away from regulatory approval.
Hundreds of retailers are offering the new drug to buyers in the US through websites such as Made-in-China.com and GorillaHealing.com. reports the Wall Street Journal.
Some of the sites, including those that appear to be based in the US, have marketed their products through posts on LinkedIn and Reddit, the publication said.
The unapproved drugs are also finding their way into consumer hands through advertisements on social media platforms and even collaborations with various spokespersons, including a fitness influencer who has put it up for sale through his newsletter.
“It is unprecedented to see a drug that is in late stages of clinical trials being so blatantly advertised online,” George Karavetsos, former director of the FDA’s Office of Criminal Investigations, told the Journal.
Counterfeit versions of Eli Lilly’s retatrutide, hailed as a potential ‘new Ozempic’, are being sold directly to US consumers
Eli Lilly generated excitement about the future of retatrutide when it announced in June that results from its Phase 2 trial showed the drug led to an average weight loss of up to 24% over 48 weeks.
Eli Lilly generated excitement about the future of retatrutide when it announced in June that results from its Phase 2 trial showed the drug led to an average weight loss of up to 24% over 48 weeks.
However, the mid-stage obesity study of retatrutide included only 338 patients.
Three late-stage studies designed to investigate efficacy and safety in many more obese patients began this summer and are expected to run until 2026.
The FDA would not approve the drug, which does not yet have a brand name, for several months afterward, assuming the trials are successful.
It can also be replicated quite easily with the right ingredients, as Eli Lilly has revealed its chemical structure in accordance with filed patent protection declarations.
Meta Platforms, which owns Facebook and Instagram, as well as Google, LinkedIn and Reddit, said it had removed ads or user posts that were flagged in accordance with its internal policies.
The FDA said it would continue to investigate reports of suspected counterfeit drugs to determine public health risks and the appropriate response from regulators.
In a statement, Lilly said: “Any product that misrepresents itself as a Lilly investigational product that has not yet been approved by the FDA, such as retatrutide, could expose patients to potentially serious health risks.”
Hundreds of retailers are offering the new drug to buyers in the US through websites such as Made-in-China.com and GorillaHealing.com
Retatrutide, together with Ozempic, made by Novo Nordisk, is part of a new class of drugs that mimic appetite-regulating hormones.
Ozempic has been back in the spotlight in recent days as its links to suicidal thoughts become more “credible,” a former US health care chief said.
The Food and Drug Administration (FDA) has received hundreds of reports of suicidal ideation and depression from patients taking weight-loss medications since 2010, as well as 36 deaths “by suicide or suspected suicide.”
Of the side effects, a significant number occurred shortly after starting the drugs or increasing the dose – only to disappear when patients stopped taking them.
Patients include a mother of four who said she felt like she no longer wanted to be here and a nurse who wanted to shoot herself.
Dr. Erick Turner, who formerly worked for the FDA but now works at Oregon Health and Science University, said the fact that many patients stopped having suicidal thoughts when they stopped taking the medication made it “harder to explain away the suicidality.”
A total of 265 reports of suicidal ideation and depression were received by the FDA Adverse Event Reporting System (FAERS).
A woman with type 2 diabetes also revealed she feared for her life after Ozempic severely burned her genitals and caused ‘chunks of skin’ to fall off her body.
Dr. Rosas, pictured above, left Ozempic after suffering side effects and says her health is now improving. She follows a strict diet to control her type 2 diabetes
Dr. Maria Rosas, who lives in Texas, said her skin developed a rash a week after starting Ozempic. She also had a burning sensation in her back and genitals
Dr. Maria Rosas, a professor in Texas, was prescribed the drug once a week for her type 2 diabetes, in the hope that it would eliminate the need to take multiple medications twice a day.
The first week went well, she said, and her blood glucose levels were well controlled. Although she felt slightly depressed, she said this quickly improved.
However, the following week, Dr Rosas said a burning pain broke out in her back, genitals and buttocks. The spots also started to turn deep red, as if they had been in the sun for ‘days’.
And then she noticed “chunks of skin” appearing on her toilet seat and toilet paper every time she cleaned those areas.
When she checked her genitals, anus and buttocks, Dr. Rosas said the skin appeared charred and burned.
Just 20 days after taking the medication in August 2023, she called her doctor to report her condition and he told her to stop taking Ozempic immediately.