FDA adds vision-loss warning to all GLP-1 drugs including Ozempic and Wegovy
The Food and Drug Administration is requiring a new warning label on GLP-1 weight-loss and diabetes medications covering a rare condition that can cause sudden, possibly permanent vision loss in one eye.
The Food and Drug Administration is adding a new warning label to all GLP-1 drugs, the class of medications that includes Ozempic, Wegovy, Zepbound and Mounjaro. The warning covers a rare eye condition called nonarteritic anterior ischemic optic neuropathy, known as NAION, which can cause sudden vision loss in one eye that may be permanent. The label will also apply to Eli Lilly's new GLP-1 pill, Foundayo.
NAION occurs when blood flow to the front of the optic nerve is reduced. People with the condition may notice a sudden, painless change in vision in one eye. The FDA has said that anyone who experiences this kind of change should contact a health care provider promptly.
The new language will appear in the « warnings and precautions » section of the drug labeling. The agency began its review after a 2024 observational study looked at semaglutide, the active ingredient in Ozempic and Wegovy, in patients with diabetes. That study found an association with NAION, but it was observational and did not prove that the drug caused the condition.
The FDA noted that several underlying conditions are linked to a higher NAION risk, including diabetes itself, smoking and sleep apnea. Those factors make it difficult to isolate the effect of the medication from the health conditions of the patients taking it.
Regulators in Europe have also examined the question. The European Medicines Agency found roughly a twofold increase in risk with semaglutide and classified the side effect as « very rare, » affecting about 1 in 10,000 users. The FDA's own estimates for the general population place the NAION rate among adults over 50 at 2.3 to 10.2 cases per 100,000 people each year.
The updated labeling reflects the agency's view that patients and prescribers should be aware of the possibility, even though the condition remains uncommon. Patients taking any GLP-1 medication who notice sudden changes in their vision should not wait to seek medical advice, the FDA said.
Source: fastcompany.com
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