Australia\u2019s Therapeutic Goods Administration (TGA) issued updated safety warnings for GLP-1 receptor agonists, a fast-growing class of diabetes and weight-loss medicines, even as the World Health Organization released its first-ever global guideline on using these drugs to treat obesity.\u00a0<\/p>\n
The TGA alert recently issued updates product information for all GLP-1 and GIP\/GLP-1 receptor agonists currently sold in Australia, including Ozempic, Wegovy, Saxenda, Trulicity, and Mounjaro.\u00a0<\/p>\n
According to the regulator, the warnings have been revised for two separate safety issues.\u00a0<\/p>\n
First, the TGA said \u201cproduct warnings across the GLP-1 RA class of medicines have been aligned to ensure consistent information regarding the potential risk of suicidal thoughts or behaviours.\u201d The move follows reviews by Australian and international regulators.\u00a0<\/p>\n
The advisory urges patients using these drugs to report mental-health changes immediately. \u201cPatients taking any of these medicines should tell their health professional if they experience new or worsening depression, suicidal thoughts or any unusual changes in mood or behaviour,\u201d the TGA warned.\u00a0<\/p>\n
The second update focuses specifically on tirzepatide (Mounjaro) and its interaction with oral contraceptives. The regulator found that \u201cthe potential for reduced effectiveness of oral contraception when first taking or increasing the dose of Mounjaro (tirzepatide) \u2026 could not be ruled out.\u201d\u00a0<\/p>\n
As a result, the TGA now advises that \u201cpatients taking tirzepatide are advised to switch to a non-oral contraceptive or add a barrier method of contraception for 4 weeks after first taking the medicine and for 4 weeks after each increase in the dose.\u201d\u00a0<\/p>\n
It also reiterated that \u201cnone of the GLP-1 RAs should be used during pregnancy and individuals of childbearing potential are advised to use effective contraception during treatment with a GLP-1 RA.\u201d\u00a0<\/p>\n
WHO issues guideline<\/b><\/p>\n
Simultaneously, the World Health Organisation released a new global guideline recommending the use of GLP-1 therapies for long-term obesity treatment.<\/p>\n
WHO Director-General Tedros Adhanom Ghebreyesus said: \u201cObesity is a major global health challenge that WHO is committed to addressing by supporting countries and people worldwide to control it, effectively and equitably.\u201d\u00a0<\/p>\n
He added that the new guidance recognizes obesity as a chronic disease requiring ongoing care: \u201cWhile medication alone won\u2019t solve this global health crisis, GLP-1 therapies can help millions overcome obesity and reduce its associated harms.\u201d\u00a0<\/p>\n
The guideline issues two conditional recommendations. First, that \u201cGLP-1 therapies may be used by adults, but excluding pregnant women, for the long-term treatment of obesity,\u201d citing clear evidence of effectiveness but cautioning about limited long-term safety data, high costs and equity concerns.\u00a0<\/p>\n
Second, WHO recommends that \u201cintensive behavioural interventions, including structured interventions involving healthy diet and physical activity, may be offered to adults living with obesity prescribed GLP-1 therapies.\u201d\u00a0<\/p>\n
However, the WHO stressed that medicines alone will not solve the global obesity crisis. The guideline warns: \u201cMedication alone won\u2019t reverse the obesity challenge,\u201d calling obesity \u201ca societal challenge that requires multisectoral action.\u201d\u00a0<\/p>\n
The organisation outlined a strategy built on three pillars: healthy environments, targeted early interventions, and lifelong person-centred care.\u00a0<\/p>\n
Concerns over access and counterfeit products<\/b><\/p>\n
WHO highlighted that even with rising production, \u201cGLP-1 therapies are projected to reach fewer than 10 per cent of those who could benefit by 2030.\u201d It called for measures such as pooled procurement, tiered pricing and voluntary licensing to avoid deepening global health inequities.\u00a0<\/p>\n
The surge in demand has also triggered a parallel market of dangerous imitations. WHO warned that \u201cthe global demand for GLP-1 therapies has fueled the spread of falsified and substandard products, threatening patient safety and trust.\u201d\u00a0<\/p>\n
Lawsuits against ozempic<\/b><\/p>\n
Recently, Ozempic was at the centre of legal trouble in the United States, where Novo Nordisk now faces more than $2 billion in claims from thousands of patients.\u00a0\u00a0<\/p>\n
More than 2,600 lawsuits have now been consolidated into a single multidistrict litigation (MDL No. 3094) in the Eastern District of Pennsylvania. Plaintiffs allege that Novo Nordisk failed to properly warn users about serious risks, including stomach paralysis, uncontrollable vomiting, intestinal blockages, pancreatitis and even vision problems. Several cases claim the drug caused \u201clife-threatening complications\u201d, with complaints now handled under Judge Karen Marston.\u00a0<\/p>\n
On the other hand, Kenya\u2019s Pharmacy and Poisons Board recently highlighted risks linked to the off-label use of semaglutide – Ozempic\u2019s active ingredient – citing concerns such as hypoglycaemia, intestinal obstruction and eye complications.<\/p>\n
However, Novo Nordisk has maintained that the medicine is safe when used as instructed.\u00a0\u00a0<\/p>\n
India\u2019s obesity challenge<\/b><\/p>\n
The controversy comes at a time when newer drugs are also entering the weight-loss space. In India, Eli Lilly\u2019s Mounjaro (tirzepatide) launched earlier this year with much fanfare.\u00a0 Manufactured by Eli Lilly, an American pharmaceutical company,\u00a0 the drug has shown significant weight loss and blood sugar benefits, leading experts to see it as a powerful tool\u2014but not a silver bullet\u2014for tackling a public health crisis that affects nearly a quarter of Indian adults.<\/p>\n
According to the World Obesity Federation\u2019s World Obesity Atlas report, if current lifestyle trends persist, over half of the global population could be overweight or obese by 2035. India is no exception. Data from the National Family Health Survey-5 (NFHS-5) suggests that nearly one in four Indians is now classified as obese. Although Mounjaro\u2019s arrival offers hope, experts like Dr Rajiv Kovil, Head of Diabetology at Zandra Healthcare, Mumbai, Maharashtra, emphasises that broader changes are needed.\u00a0<\/p>\n
Dr Kovil explains that Mounjaro works by activating both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptors, unlike drugs like Ozempic, which target only GLP-1.\u00a0\u00a0<\/p>\n
GIP is a hormone that stimulates insulin release after eating, helping to regulate blood sugar.\u00a0<\/p>\n
\u201cThis dual action helps Mounjaro control blood sugar by boosting insulin and lowering glucagon. It also supports weight loss by slowing digestion, reducing appetite, and promoting fat loss,\u201d Dr Kovil told First Check in a recent interview.\u00a0\u00a0<\/p>\n