Canberra , December 8, 2025 :
Australia’s drug regulator has issued an urgent safety alert for popular diabetes and weight-loss drugs like Ozempic and Mounjaro, warning of potential mental health risks including suicidal thoughts and sudden mood changes. The Therapeutic Goods Administration (TGA) has updated product information across the entire GLP-1 receptor agonist class—mimicking natural hormones to control blood sugar and aid weight loss—urging doctors to monitor patients closely for depression, self-harm behaviors, or unusual emotional shifts.
The warning stems from TGA’s analysis of its Database of Adverse Event Notifications (DAEN), which revealed 72 reports of suicidal ideation linked to these drugs by September 2025. Among them: six suicides, four attempts, and two self-harm incidents potentially tied to GLP-1 use. While no definitive causal proof exists—experts note complex overlaps with obesity-related mental health issues—the TGA emphasizes precaution, especially since these meds are prescribed in massive numbers globally. Affected drugs include Ozempic (semaglutide), Mounjaro (tirzepatide), Wegovy (semaglutide), Saxenda (liraglutide), and Trulicity (dulaglutide).
For Mounjaro specifically, the TGA couldn’t rule out reduced effectiveness of oral contraceptives when starting or increasing doses, advising users to switch to non-oral methods or add barriers for four weeks post-initiation or dose hikes. Pregnant women should avoid these entirely.
This alert raises red flags for India, where demand for GLP-1 drugs is exploding amid a diabetes crisis affecting 101 million adults. In October 2025 alone, Mounjaro raked in nearly ₹100 crore ($11.38 million) in sales, topping the Indian Pharmaceutical Market (IPM) by value with 2.6 lakh units sold—priced ₹14,000–₹27,500 per monthly dose. Cumulative sales since its March launch hit ₹333 crore, outpacing rivals like Ozempic (set for December launch) and Wegovy. With obesity claiming 3.7 million lives globally in 2024 (WHO estimate) and affecting over 1 billion people, these drugs offer hope but demand vigilant oversight.
The World Health Organization (WHO) echoes the caution in its first-ever guideline on GLP-1 therapies for obesity, released December 1, 2025. Hailing them as a “scientific breakthrough” for chronic obesity management—added to the Essential Medicines List in September for high-risk type 2 diabetes—it stresses comprehensive care: meds plus diet, exercise, and behavioral support. WHO conditionally recommends GLP-1s for adults (excluding pregnant women) but warns of equitable access challenges, projecting only 100 million users by 2030 amid skyrocketing costs (global obesity burden: $3 trillion annually).
Experts like those from the Advisory Committee on Medicines (ACM) note mixed evidence—some studies show slightly elevated risks vs. other diabetes drugs, others lower—but urge regular monitoring. A 2024 WHO database analysis flagged higher-than-expected suicidal reports for semaglutide, prompting international scrutiny.
