FDA requires new eye-risk warnings on GLP-1 medicines

Health · First reported 9 Nov, 18:14 · Updated 18:40

Image: Wikimedia Commons · Ysherazi · CC BY-SA 4.0

The FDA is requiring GLP-1 drugmakers to warn about a potential link to NAION, a rare eye condition that can cause permanent vision loss. The agency found reports across marketed products but could not establish how the medicines might raise the risk.

The FDA is requiring warning-label updates for GLP-1 medicines about a potential increased risk of NAION, a rare condition that can cause permanent vision loss.
The FDA said it found NAION reports across marketed GLP-1 products, but could not identify a mechanism linking the drugs to the condition; it also noted that risk factors overlap with conditions common among patients taking them.
A 2024 study found diabetes patients prescribed semaglutide were four times as likely to develop NAION as those not prescribed it. The FDA says patients should report vision changes to a health care professional.

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Key facts

Condition: Nonarteritic anterior ischemic optic neuropathy (NAION), which can cause permanent vision loss.
FDA finding: The agency concluded there is a potential increased risk of rare NAION events among GLP-1 users.
Study cited: A 2024 study found diabetes patients prescribed semaglutide were four times as likely to develop NAION as those not prescribed it.
Reported cases: The FDA said NAION cases had been reported for all currently marketed GLP-1 drugs.
Known mechanism: The FDA said it could not identify a mechanism explaining how GLP-1 drugs might increase risk.