South Africa's medicines regulator has warned the public not to buy or use products sold online claiming to be glucagon-like peptide 1 (GLP-1) weight loss drugs, saying they pose a health risk.
The South African Health Products Regulatory Authority (Sahpra) said it had identified “a significant number” of websites offering illegal sales of products that claimed to be versions of Novo Nordisk’s semaglutide, better known as Ozempic, or Eli Lilly’s tirzepatide, branded Mounjaro.
GLP-1s are a class of drugs originally developed for treating type 2 diabetes that are now increasingly used to treat obesity. They stimulate the pancreas to release insulin and suppress the release of the hormone glucagon, which help to control blood sugar levels in people with type 2 diabetes. They also act in the brain to reduce hunger and delay the stomach from emptying, so people feel full for longer.
Their success in promoting weight loss has triggered sales of fake, substandard and compounded GLP-1 products promoted online, on social media and in other informal channels, said Sahpra, emphasising the safety and efficacy of those products has not been assessed.
These drugs, which are administered as injections, can legitimately be prescribed in South Africa 'off label' for weight management
— Deon Poovan, Sahpra acting chief regulatory officer
While Sahpra approved several GLP-1 drugs for treating diabetes, including Novo Nordisk’s semaglutide and liraglutide (branded Victoza), and Eli Lilly’s tirzepatide, none are registered for weight management in South Africa, said Sahpra acting chief regulatory officer Deon Poovan.
These drugs, which are administered as injections, can legitimately be prescribed in South Africa “off label” for weight management, as they are registered for this purpose by other respected medicines regulatory authorities, such as the US Food and Drug Administration, he said. They cannot legally be sold directly to the public, either online or through other channels.
Sahpra was particularly concerned about the sale of unauthorised compounded GLP-1 products as they posed a significant health and safety risks, said Poovan. Compounded drugs are custom-made and can be legally prescribed if a patient requires a non-standard dose, he added. However, unauthorised compounded GLP-1 products contain active pharmaceutical ingredients that are not registered in South Africa and are therefore illegal. The active ingredients may be substandard and the final product may contain the wrong dose, he cautioned.
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 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 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 who falsely claimed their products were Mounjaro. “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.
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