FDA to require GLP-1 makers to add major change to warning labels

• The FDA will require manufacturers of GLP-1 weight-loss drugs to include warnings about a rare eye condition that can cause permanent vision loss.
• The condition, known as NAION or an eye stroke, stems from reduced blood flow to the optic nerve and currently has no treatment.
• An FDA review found six cases of NAION per 100,000 GLP-1 users annually, compared to four per 100,000 among those taking a placebo or alternative diabetes drugs.
• Nearly 28 million Americans use GLP-1 medications, and the FDA urges patients experiencing sudden vision changes to consult a healthcare professional immediately.
• Drugmakers Novo Nordisk and Eli Lilly emphasized patient safety, with Novo Nordisk noting that data does not establish a direct cause-and-effect relationship.

IN FULL

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