FDA adds rare vision-loss warning to GLP-1 drugs

...developing story that will surely raise new health questions. The FDA is warning health care providers and patients of a possibly higher risk of vision impairment with two of the most popular weight loss drugs on the market. It's already on the labels in Europe and Australia, but now the FDA is saying it's time to do the same here. The focus of the new mandated warnings is a condition called NAION, a sudden onset of vision impairment or blindness that can be permanent. The Food and Drug Administration now requires... Requiring GLP-1 drugs such as Eli Lilly's Mounjaro and Zepbound and Novo Nordisk's Ozempic and Wegovy to add information to the warnings and precautions section of labeling about the potential increased risk of NAION. Patient safety is Lilly's top priority. FDA's drug safety communication applies to all medicines with GLP-1 RA activity and does not reference any findings specific to Lilly medicines. We are carefully evaluating the update and will respond to the FDA promptly. That was the Lilly statement. Now here's Novo. Novo continues to believe the data does not establish a cause and effect relationship and we remain confident in the benefit-risk profile of our GLP-1 medicines. Attorney Jason Goldstein, senior litigation counsel for the Parker Weitzman law firm, is representing many clients claiming to suffer from NAION in a major federal lawsuit against the drug companies. He'll never forget one of his first. One of my first clients from New York, 48-year-old guy, woke up one morning blind in one of his eyes, can't see, permanently is unable to do all the activities he enjoyed, harder to go to work, everything. I mean, imagine being that young, taking a drug to lose some weight, and then you lose a part of your eyesight as a result of it. Now, the FDA says it has evaluated clinical trial data, animal data and post-marketing data, including observational studies and case reports. The KFF Health Policy Institute estimates that about one in five Americans, roughly 45 to 48 million people, report having taken a GLP-1 at some point.