FDA Requires Eye-Risk Warnings on GLP-1 Medicines

The U.S. Food and Drug Administration is requiring manufacturers of GLP-1 medicines to add warnings about a potential risk of nonarteritic anterior ischemic optic neuropathy, or NAION, a rare condition that can cause sudden, painless vision loss and sometimes permanent impairment. The change applies across the drug class, which is used to treat obesity and type 2 diabetes.

The FDA said it reviewed clinical trials, animal data and postmarketing reports, including observational studies and case reports. Its assessment found a potential increased risk but does not establish that the medicines cause NAION. Cases have been reported across currently marketed GLP-1 products, the agency said.

In a meta-analysis of randomized trials involving more than 134,000 patients, the FDA identified 15 probable cases: 10 among roughly 78,000 patients assigned GLP-1 medicines, none among those assigned other glucose-lowering drugs and five among placebo recipients. The agency reported an incidence of 6.4 cases per 100,000 person-years among GLP-1 recipients, compared with 3.8 among patients receiving placebo or non-GLP-1 medicines.

A separate FDA study of people with type 2 diabetes found different...