TGA Updates Warnings for Popular Weight-Loss and Diabetes Drugs
Australia's Therapeutic Goods Administration (TGA) has updated the product information for GLP-1 receptor agonist medicines—including Ozempic, Wegovy, and Mounjaro—to include a new warning about a rare but severe eye disorder.
The condition, known as non-arteritic anterior ischaemic optic neuropathy (NAION), can cause permanent vision loss.
The Link to NAION
The TGA identified 36 cases of NAION linked to these drugs:
- 23 cases with semaglutide (Ozempic/Wegovy)
- 10 cases with tirzepatide (Mounjaro)
- 3 cases with liraglutide (Saxenda)
No cases were reported with dulaglutide (Trulicity).
The regulator states that NAION may result in permanent visual impairment, adding that currently no treatment exists to improve visual acuity after onset.
What Patients Should Do
The TGA urges patients to seek urgent medical attention if they experience sudden vision loss. However, it does not recommend stopping treatment without first consulting a doctor. No new prescription restrictions have been imposed.
Expert Perspective
Prof. Helen Danesh-Meyer from the Royal Australian and New Zealand College of Ophthalmologists said NAION is "a very rare condition". She noted that the benefits of these medications for managing diabetes and obesity—which reduce risks of heart attack, stroke, and kidney disease—likely outweigh the risk for most patients.
Background
The TGA first became aware of the potential link in 2024 after a peer-reviewed study. It conducted an independent assessment and sought advice from the national advisory committee on medicines, which concluded that updated safety warnings were warranted. The national database of suspected adverse events recorded the 36 cases.