Big Pharma in South Africa and the US is calling for urgent crackdown on illegal medicines, especially unregulated obesity drugs like retatrudite, which is being linked to at least two deaths overseas, reports MedicalBrief.
“Where there are slam-dunk cases, and evidence has been sent to the South African Police Service and others, we need to see action,” said Pharmaceutical Task Group (PTG) chair Dr Stavros Nicolaou, according to Business Day.
He is pleading for immediate action, in particular, against the sale of unregistered medicines like Eli Lilly’s experimental obesity drug retatrutide, which has not been approved by South African regulatory authorities – or any other authorities yet.
Global illicit sales of the drug are flourishing because clinical trials have shown it to be one of the most powerful weight loss products in development – with consumers shedding up to 18.8% of their body weight, depending on their dose, according to a Lancet report published last week.
Eli Lilly has said it plans submit its application for regulatory approval to the US Food and Drug Administration in the first quarter of next year.
Meanwhile, despite having not yet been declared safe and effective, it is being “openly and brazenly” sold in South Africa by social media influencers, gym instructors and hairdressers, said Nicolaou, senior executive at generic drug manufacturer Aspen Pharmacare.
Aspen has an agreement to promote and distribute Eli Lilly’s Mounjaro in South Africa and other Sub-Saharan African countries, and is also pursuing the market for generic semaglutide, originally developed by Novo.
Nicolaou urged the authorities to prosecute even small businesses and individuals who broke the law.
“You have to send messages of strong deterrence to society, and you have to start with the less sophisticated [criminals],” he said. “Otherwise, before you know it, the public and healthcare providers are going to question the integrity of the regulatory system we have in place.”
US deaths linked to ‘Reta’
In America, the Food and Drug Administration has logged two reports of people who died after allegedly taking bootleg versions of the drug, reports CBS News.
As in South Africa, the drug hasn’t yet been approved there either, but vendors are selling imitation versions of the experimental drug online at a scale with no modern precedent.
The first death reportedly occurred in July, when a 41-year-old woman went into cardiac arrest. The report lists retatrutide as a “suspect product”, and that the woman had obtained it “from an unreliable source”.
Then in September, the FDA received a report that a 49-year-old patient died after a licensed nurse “convinced” her to buy retatrutide from an online peptide vendor: she experienced severe dehydration, malnutrition and cardiac arrest.
Though the reports alone don’t prove that the drugs caused or contributed to patient deaths, they point to the potential dangers of an illicit market for unapproved drugs like retatrutide.
“It is concerning because of the breakdown of our drug-approval process in the United States,” said Pieter Cohen, an associate professor at Harvard Medical School.
“The FDA should do whatever it can to to get its hands on the actual drug injected by both of these patients, and get that analysed. If the FDA is not aggressively investigating these cases, that’s deeply concerning.”
Previous investigations by CBS News have found the drug widely available in health spas, on wellness websites and even in some convenience stores. Dozens of medical professionals have openly promoted access to retatrutide, and some sellers have been aided by an independent, blue-chip certification that gives them the appearance of legitimacy and the ability to advertise it on social media.
The reported deaths were submitted to the FDA's Adverse Event Reporting System.
The FDA declined to say whether it has verified any of the information in either reported death.
America’s Poison Centres has tallied a steady increase in reported exposures to retatrutide since it began tracking them late last year, which is common for a newly monitored drug. It logged 862 exposures to retatrutide in the three months ending in September, up from 460 in the three months prior and 249 in the first three months of 2026.
Earlier this year, Eli Lilly said serious heart-related reactions to the drug “occurred less frequently than anticipated” in patients who received retatrutide as well as those who got a placebo, while the drug reduced certain measures of cardiovascular risk.
In a statement, the company said that the reported deaths “make it clear the two individuals were taking black-market retatrutide”. It said it has found suspect products “with too much, too little, or the wrong active ingredient”, along with contaminants that “can put patients at serious risk”.
It is taking legal action against companies selling bootleg versions of its drug.
Expired meds …
Meanwhile, Western Cape police have also issued a warning about buying any medicines off the street after the arrest last week of a vendor at the Nyanga Junction taxi rank.
IOL reports that the man (38), was selling medicines, ointments and blister packs of various pills – many of which had expired. The vendor, who was unable to tell police where the stock came from, was taken into custody and will appear in court for contravening the Medicines Act once formally charged.
Study details
Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial
Virginia Bellido, Carel W le Roux, Elif Ekinci et al.
Published in The Lancet on 10 October 2026
Summary
Background
Retatrutide is an agonist of GIP, GLP-1, and glucagon receptors, and is currently under investigation for the treatment of obesity, type 2 diabetes, and other comorbidities, including knee osteoarthritis and obstructive sleep apnoea. We aimed to assess the efficacy and safety of retatrutide in adults with obesity and type 2 diabetes.
Methods
TRIUMPH-2 was a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial conducted at 92 medical and research centres and hospitals across eight countries. We enrolled adults (aged ≥18 years) with a BMI of 27 kg/m2 or higher and type 2 diabetes (glycated haemoglobin [HbA1c] 6·5–10·5%) on stable treatment for type 2 diabetes for at least 90 days before screening (diet or exercise alone, or up to three oral glucose-lowering medications), and a history of at least one self-reported unsuccessful dietary effort to reduce bodyweight. Participants were randomly assigned (1:1:1:1), using an interactive web-response system, to receive once-weekly subcutaneous injections (self-administered) of placebo or retatrutide 4 mg, 9 mg, or 12 mg. The primary endpoint was the percentage change from baseline to week 80 in bodyweight for the retatrutide 9 mg and 12 mg doses versus placebo, with 4 mg versus placebo a key secondary endpoint. Efficacy analyses included all randomly assigned participants, with missing data imputed with a primary multiple imputation strategy for the treatment regimen estimand. Safety analyses included all randomly assigned participants who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT05929079 (completed).
Findings
Between July 11, 2023, and Nov 1, 2024, 2047 participants were screened, and 1152 (mean age 55·1 years [SD 10·8], 554 [48%] females and 598 [52%] males, and 672 [58%] of White ethnicity) were randomly assigned to retatrutide 4 mg (n=292), 9 mg (n=284), or 12 mg (n=287), or placebo (n=289). At baseline, the mean BMI was 38·2 kg/m2 (SD 7·4), mean HbA1c was 7·71% (1·07), median duration of obesity was 21 years (IQR 11–31), and median duration of diabetes was 5·6 years (2·6–10·4). At baseline, 1055 (92%) of 1152 participants were on any oral glucose-lowering medication, including biguanides, SGLT2 inhibitors, sulfonylureas, and other oral glucose-lowering medications. Of 1152 participants, 965 (84%) completed the study drug. For the treatment regimen estimand, the mean percentage change from baseline in bodyweight at week 80 was −11·9% (SE 0·6) with retatrutide 4 mg, −16·8% (0·7) with retatrutide 9 mg, −18·8% (0·7) with retatrutide 12 mg, and −5·1% (0·7) with placebo. Estimated treatment differences compared with placebo for percentage change in bodyweight were −6·9% (95% CI −8·7 to −5·1) with retatrutide 4 mg, −11·8% (−13·7 to −9·8) with retatrutide 9 mg, and −13·8% (−15·8 to −11·8) with retatrutide 12 mg (p<0·0001 for all). The most frequently reported adverse events were gastrointestinal, which were more common in the retatrutide groups than in the placebo group (diarrhoea occurred in 80 [27%] of 292 participants in the 4 mg group, 95 [34%] of 284 in the 9 mg group, and 96 [34%] of 286 in the 12 mg group vs 38 [13%] of 287 in the placebo group, and nausea occurred in 40 [14%], 59 [21%], and 80 [28%] vs 23 [8%]). Hypotension and dysesthesia were more frequent with retatrutide than with placebo (four [1%] in the 4 mg group, 14 [5%] in the 9 mg group, and 18 (6%) in the 12 mg group vs one [<1%] in the placebo group with hypotension; 13 [4%], 16 [6%], and 21 [7%] vs two [1%] in the placebo group with dysesthesia). Permanent treatment discontinuation due to adverse events or death was more frequent in participants treated with retatrutide 9 mg (33 [12%]) and 12 mg (22 [8%]) compared with retatrutide 4 mg (11 [4%]) and placebo (14 [5%]). Two participants died in the retatrutide 4 mg group, three in the 9 mg group, one in the 12 mg group, and one in the placebo group; all deaths were deemed to be unrelated to the study intervention by the investigator.
Interpretation
Treatment with retatrutide resulted in substantial improvements in bodyweight and was associated with improvements in glycaemic control in participants with obesity and type 2 diabetes, with a safety profile generally consistent with other molecules with GLP-1 receptor agonism. These results show that retatrutide might be effective for the treatment of obesity in people with type 2 diabetes.
See more from MedicalBrief archives:
Warning after peptide user’s oesophagus tears from fake product
Hundreds of websites flog fake weight-loss and other drugs
Millions lost to dangerous fake drugs, warns Motsoaledi
Call for action on booming fake drugs trade in SA