The FDA is officially requiring pharmaceutical companies to add information about the risk of a rare but serious eye condition to the Warnings and Precautions section of their GLP-1 medications.
The FDA announced on Monday — after an intensive review of studies and clinical trials — that GLP-1 use is associated with an “potential increased risk” of a condition called Nonarteritic Anterior Ischemic Optic Neuropathy (NAION).
While the condition is painless, NAION occurs when blood flow to the front part of the optic nerve is suddenly reduced or cut off, resulting in decreased vision or blindness in one eye. The condition is often called an “eye stroke.”
As a result of the FDA’s finding, pharma companies, including the makers of Ozempic and Zepbound, among others, will now be required to add a warning about NAION to their labeling.
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