Australia's medicines regulator has issued a warning regarding a potential link between several type 2 diabetes and obesity treatments, including Ozempic and Mounjaro, and a rare but severe eye disorder. The Therapeutic Goods Administration (TGA) stated that non-arteritic anterior ischaemic optic neuropathy (NAION) may result in permanent visual impairment, and no treatment has proven effective after the condition develops.
Product information documents for these medications in Australia have been updated to include the new warning. Patients prescribed these drugs are advised to seek urgent medical attention if they experience sudden vision loss. However, the TGA does not recommend discontinuing treatment without consulting a doctor, and no new prescription restrictions have been imposed.
Professor Helen Danesh-Meyer from the Royal Australian and New Zealand College of Ophthalmologists emphasized that NAION is a very rare condition and should be viewed in perspective, given the common and life-threatening risks associated with diabetes and obesity that these medications help manage. She noted that the medications have revolutionized diabetes and obesity management, suggesting doctors should not withhold them unless a patient has pre-existing eye conditions.
The TGA became aware of the potential link in 2024 following a peer-reviewed study and has since closely monitored further evidence. An independent assessment by the TGA found conflicting evidence regarding the association between GLP-1 RAs and NAION. The national advisory committee on medicines advised that the current evidence warranted further action, including updated consumer and clinical safety warnings.
The national database of suspected adverse events has recorded 36 cases of NAION linked to these drugs. Ozempic and Wegovy accounted for 23 of these cases, Mounjaro for 10, and Saxenda for three. No cases were reported for dulaglutide (Trulicity).