FDA warns GLP-1 diabetes, obesity drugs may cause eye-stroke
What's the story
The US Food and Drug Administration (FDA) has ordered all makers of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) to add a warning about the risk of non-arteritic anterior ischemic optic neuropathy (NAION) to their product labels. The move follows the agency's finding of a possible increased risk of the rare but serious eye condition with popular diabetes and weight-loss drugs, including Ozempic, Wegovy, Saxenda, and Mounjaro.
Condition explained
What is NAION and how does it affect vision?
NAION, often referred to as an "eye-stroke," is caused by reduced blood flow to the optic nerve.
This vital nerve carries visual information from the eye to the brain.
When its blood supply is interrupted, it can lead to sudden vision loss in one eye.
The FDA has advised patients taking GLP-1 RAs who experience sudden, painless changes in vision to contact their healthcare professional immediately.
Risk assessment
Increased risk of NAION with GLP-1 medicines
The FDA's decision was based on a comprehensive review of clinical trial data, animal studies, adverse-event reports, and observational research.
A meta-analysis of 126 randomized controlled clinical trials with 1,34,253 participants found 15 cases of NAION, 10 among those taking GLP-1 medicines and five among those receiving comparator treatments.
While the condition is rare, it was more common among people taking GLP-1 medicines in this analysis.
Data analysis
Analysis of real-world health data on NAION risk
The FDA also reviewed real-world health data from adults with Type 2 diabetes who began taking GLP-1 medicines between 2019 and 2024.
That analysis found no statistically significant increase in NAION risk when GLP-1 medicines were compared with SGLT-2 inhibitors, another class of diabetes drugs.
However, the risk was higher when compared with DPP-4 inhibitors, leading the agency to require manufacturers to update their safety information based on the combined evidence.
Warning scope
Which GLP-1 medicines are implicated?
The FDA's warning applies to all popular brands in the GLP-1 receptor agonist class, including Ozempic and Wegovy (semaglutide), Rybelsus (oral semaglutide), Saxenda and Victoza (liraglutide), Trulicity (dulaglutide), Mounjaro and Zepbound (tirzepatide), and Foundayo (orforglipron).
Cases have been reported across all currently marketed GLP-1 receptor agonist products, per Firstpost.
However, the agency has not advised everyone taking these medicines to stop treatment.
Risk assessment
Risk factors for NAION
NAION is linked with various underlying health conditions like diabetes, high blood pressure, smoking, anemia, sleep apnea, and kidney disease.
The FDA has not established exactly how GLP-1 medicines might contribute to the condition, and it has not advised everyone taking them to stop treatment.
Patients diagnosed with NAION while on a GLP-1 medicine should discuss whether treatment should be discontinued with their healthcare professional.