WeeklySA_AdminVERSIONS: Public alert follows recent deaths of 10 people and hospitalisation of 100 others in the US after using copycats of highly popular slimming brand – Ozempic – currently sold online and some health spas…
By Own Correspondent
Compounded versions of hugely popular weight-loss and obesity drugs, which have led to the deaths of at least 10 people and 100 hospitalisations overseas, have prompted warnings from the drug manufacturers and SA Health Products Regulatory Authority (SAHPRA).
SAHPRA this week appealed to the public not to buy compounded versions of the drugs, saying there has been a concerning rise in falsified versions of these products being offered on websites and various social media platforms.
It cautioned that the safety and quality of the products, many of which are sub-standard, have not been assessed.
The warning follows last week’s global message from the CEO of Ozempic maker Novo Nordisk, who said compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy, have been associated with at least 100 hospitalisations and 10 deaths in the US.
“Honestly, I’m quite alarmed,” Novo Nordisk President and CEO Lars Fruergaard Jorgensen told CNN.
“Patients believe that they’re getting access to a safe product, and that they’re getting semaglutide … I know for a fact that they are not getting semaglutide, because there’s only one semaglutide, and that’s produced by Novo Nordisk, and we don’t sell that to others.”
SAHPRA said compounded, substandard and/or falsified versions of Ozempic (semaglutide) as well as Mounjaro (tirzepatide) were being touted on various platforms.
Ozempic is registered in South Africa for the treatment of type 2 diabetes and for the reduction of risk of major adverse cardiovascular events such as heart attack or stroke. It is not registered in this country for weight management.
Mounjaro (tirzepatide), from Eli Lilly, is indicated for the treatment of type 2 diabetes mellitus but has not yet been imported into and placed on the market in South Africa. Mounjaro is currently also not registered in South Africa for weight management.
Africa’s biggest drug maker, Aspen Pharmacare, which clinched a marketing and distribution agreement with Eli Lilly last year for a portfolio of its drugs that includes Mounjaro, said SAHPRA was currently reviewing an application for it to be used for chronic weight management.
Eli Lilly was the only lawful supplier of tirzepatide medicines and did not provide it to compounding pharmacies, med-spas, wellness centres, online retailers or other manufacturers, said Aspen’s head of strategic trade Stavros Nicolaou.
“Lilly does not know where compounding pharmacies or other sellers are obtaining the tirzepatide active ingredient they are using and selling, and suffice to say these are from sources that carry patient risk as they are untested,” he said.
The company would pursue legal remedies against those that falsely claimed their products were Mounjaro, he told BusinessLIVE.
“Lilly strongly supports global regulators and law enforcement taking action to deter those who put patients at risk by selling unsafe or fake products claiming to be tirzepatide,” he said.
Novo Nordisk said the data on 10 American deaths and more than 100 hospitalisations came from the US Food and Drug Administration’s (FDA) adverse event-reporting database for semaglutide.
Compounded drugs, made by pharmacies or manufacturers other than the companies that make FDA-approved versions of the medicines, are typically allowed when drugs are in shortage.
Semaglutide and tirzepatide had been on the FDA’s shortages list since 2022, and the popularity of the medicines, in the GLP-1 receptor agonists class, had led to entire businesses built on compounded versions.
Last month, the FDA said it had received “multiple reports of adverse events, some requiring hospitalisation, that may be related to dosing errors associated with compounded injectable semaglutide products.
The agency also warned that some compounders may be selling salt forms of semaglutide, which are different active ingredients than those in the approved drugs, and that counterfeit forms of Ozempic are also being sold.
In October, the FDA said the shortage of tirzepatide, sold by Eli Lilly as Mounjaro for diabetes and Zepbound for obesity, had been resolved, which was expected to reduce the mass compounding of the medicine.
But the agency said later it was re-evaluating the decision that the shortage is over amid litigation, putting compounding of tirzepatide into a grey area.
Semaglutide, meanwhile, remains on the shortages list, but Novo Nordisk hopes it won’t be for long. The company last week noted that the last remaining dose in short supply, the lowest dose of Wegovy, is now listed as available.
The FDA told CNN last week that it’s “currently working to determine whether the demand or projected demand for semaglutide within the United States exceeds the available supply”.
The agency’s adverse event database for semaglutide shows 10 deaths among patients potentially associated with compounded semaglutide since 2023. It also lists almost 500 additional deaths for semaglutide not flagged as being related to compounding.
Drug tied to nurse’s death
Meanwhile, the death of a Scottish nurse has been linked to Mounjaro, which was recently approved for use on the British NHS.
It is thought to be the first death officially linked to the drug in the UK, reports the BBC.
Susan McGowan (58) took two low-dose injections of Mounjaro over the course of about two weeks before her death in September. Her death certificate lists multiple organ failure, septic shock and pancreatitis as the immediate cause of death – but “the use of prescribed tirzepatide” is also recorded as a contributing factor.
She had bought a prescription via a registered online pharmacy but days after her second injection started having severe stomach pains and sickness.
Family were told by doctors that her kidneys were not functioning properly. Days later she went into a coma, and her organs began to fail.
Tirzepatide was approved for use as a weight-loss aid in the UK in 2023 by the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA runs a yellow card scheme where reports of suspected side effects of drugs can be logged, and between January and May 2024, there were 208 reports about tirzepatide, including 31 serious reactions and one suspected death.
Naveed Sattar, professor of metabolic medicine at the University of Glasgow and Chair of the UK Government’s Obesity Mission, said it was difficult to establish cause and effect in single cases where patients die after taking the drugs.
“Trials are very robust in trying to establish safety, and that the drugs generally have substantial benefits which outweigh the risks.”
Tirzepatide became the subject of national debate recently when the UK government announced plans to roll it out to unemployed people to help them back into work.
The government is partnering with Eli Lilly to run a five-year study involving up to 3 000 people. Separately, there are proposals by NHS England for an evaluation of the drug, which will involve nearly 250 000 people. – Medicalbrief
