The safety mandate applies to all marketed GLP-1 medications following an extensive review of published literature, real-world data, and clinical trial results. An examination of 126 clinical trials comprising more than 134,000 participants identified a higher frequency of the optic nerve condition among drug recipients than those on placebos or alternative treatments. While the FDA has not firmly established causation, corroborating observational studies justified the class-wide warning updates.
Key points
Patients taking GLP-1 medications showed higher rates of a blinding eye condition than th…: Patients taking GLP-1 medications showed higher rates of a blinding eye condition than those taking alternative therapies.
The FDA determined that cases of the rare eye disease have emerged across every marketed…: The FDA determined that cases of the rare eye disease have emerged across every marketed GLP-1 medication.
Federal health officials implemented the label changes despite the lack of a formally est…: Federal health officials implemented the label changes despite the lack of a formally established causal relationship.
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The U.S. Food and Drug Administration is requiring new safety warnings on all GLP-1 drugs after finding evidence of a potential increased risk of a rare eye condition, the agency said on Monday.
The condition, which can cause sudden vision loss, known as nonarteritic anterior ischemic optic neuropathy (NAION), is rare, and a causal relationship has not been established.
The FDA is requiring the makers of all GLP-1 medications to add a warning about the potential increased risk of NAION associated with use of these medications, it said.
NAION is a condition that can result in sudden decreased vision, including permanent vision loss. It is caused by decreased blood flow to the front part of the optic nerve — the underlying cause is not completely understood, however.
NAION cases have been reported for all currently marketed GLP-1 products, the FDA said.
CNBC has reached out to Ozempic and Wegovy maker Novo Nordisk and Eli Lilly, the company behind Mounjaro, Zepbound and Foundayo, for comment.
The FDA decision follows a review of clinical trials, real-world patient data, and published studies.
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