FDA requires GLP-1 makers to warn of rare vision-loss risk

The FDA is requiring makers of all GLP-1 medications to add a warning about a potential increased risk of nonarteritic anterior ischemic optic neuropathy, or NAION. The rare condition can cause sudden decreased vision, including permanent vision loss. It is caused by decreased blood flow to the front part of the optic nerve. The FDA said a causal relationship between the drugs and NAION has not been established, and cases have been reported for all currently marketed GLP-1 products.

An analysis of 126 trials involving more than 134,000 patients found 6.4 cases of NAION per 100,000 patient-years among GLP-1 users, compared with 3.8 among patients receiving other treatments or placebos. The FDA identified 15 probable events, 10 in patients treated with GLP-1s and five in patients receiving a placebo. It identified no cases among patients receiving other non-GLP-1 glucose-lowering medications.