US is requiring weight-loss drug makers to warn about possible loss of eye sight

The makers of blockbuster weight loss drugs such as Ozempic and Zepbound will be required to include warnings about a rare eye condition that can cause permanent vision loss.Taking GLP-1 medications carries an increased risk of a rare condition known as “non-arteritic anterior ischemic optic neuropathy,” or NAION, the U.S. Food and Drug Administration said Monday.NAION can result in painless but decreased vision in one eye, caused by reduced blood flow to part of the optic nerve. It’s sometimes referred to as an “eye stroke.”There is no treatment for the condition, though the first cases were reported at the beginning of the 19th century.“NAION cases have been reported for all currently marketed GLP-1 RA products,” the FDA says. “FDA concluded that there is a potential increased risk of rare NAION events in patients taking GLP-1 RAs.”The FDA is requiring GLP-1 drugmakers to include warnings about an eye condition that can lead to permanent vision loss (AFP/Getty)The decision follows a comprehensive review of NAION in patients who were taking the drugs, incorporate reports received through the FDA’s Adverse Event Monitoring System and studies involving more than 134,000 patients.The analysis found about six cases of NAION per 100,000 people taking GLP-1 drugs each year, compared with about four cases among those taking a placebo or other diabetes medication.“Based on published literature, the incidence of NAION in the general population is 2.3 to 10.2 cases per 100,000 persons per year in adults older than age 50. Patients with a history of NAION are at increased risk of recurrence,” the FDA wrote.The analysis follows a May review from the American Academy of Ophthalmology and the North American Neuro-Ophthalmology Society that found using semaglutide-based GLP-1s may be tied to “about a two-fold increase in relative risk of NAION.”The Independent has reached out to top drugmakers Novo Nordisk, Eli Lilly and Sanofi for comment on the matter.While drugmakers have the ability to challenge FDA safety labeling changes, the agency determines whether they will be required to add them. A spokeswoman for Eli Lilly told The Wall Street Journal that patient safety is the company’s top priority and that the company is evaluating the FDA’s update and would soon respond.Roughly 28 million Americans are taking GLP-1 drugs, according to a July Gallup poll.About half of patients on GLP-1s stop taking the drugs within their first year, partially due to gastrointestinal side effects, a study of 125,000 patients published by scientists in Pennsylvania and the Pacific Northwest last year found.This is a developing story.