The FDA is requiring makers of all GLP‑1 receptor agonist drugs to add a warning about non-arteritic anterior ischemic optic neuropathy, or NAION, a rare condition that can cause sudden and sometimes permanent vision loss in one eye. The agency announced the change in a drug safety communication1 dated Nov. 9.
The warning covers the whole class, including Ozempic, Wegovy, Rybelsus, Mounjaro, Zepbound, Trulicity, Victoza, Saxenda and the new Foundayo pill.
The FDA said it found a potential increased risk after reviewing several kinds of evidence. A pooled analysis of 126 clinical trials with about 134,000 patients found NAION at a rate of 6.4 cases per 100,000 person-years with GLP‑1 drugs, compared with 3.8 with placebo or other diabetes medicines. A study in the FDA's Sentinel database also found a higher risk compared with an older class of diabetes pills.
In absolute terms, the condition remains rare. The difference works out to roughly three extra cases for every 100,000 people taking the drugs for a year.
The agency advised patients to contact a clinician right away for sudden, painless vision loss in one eye, often noticed on waking, as well as new blind spots, blurred patches or faded colors. Known risk factors for NAION include diabetes, high blood pressure, sleep apnea, smoking and kidney disease, conditions common among people prescribed these drugs. Anyone who has already had NAION should talk with a prescriber about whether to continue.
The FDA did not advise people to stop their medication. For a broader look at the newest options in this class, see our comparison of the two GLP‑1 pills.
