concise.news
OriginalSourceQuartzUnited StatesLeanUnratedCredibilityUnratedPublished18:50 UTCSourceQuartzUnited StatesLeanUnratedCredibilityUnratedPublished18:50 UTC

“FDA is requiring weight loss drug makers to add a vision loss warning”

“The warning covers all GLP-1 drugs, including Ozempic, Wegovy, Mounjaro and Zepbound, over a rare eye condition called NAION”

FDA requires vision loss warning on GLP-1 weight loss drug labels

Key points

  • FDA mandates warning about NAION, an uncommon eye disorder risking permanent vision loss.
  • Label changes apply to Ozempic, Wegovy, Mounjaro, Zepbound and Foundayo.
  • Warning appears in the Warnings and Precautions section of drug labeling.
  • Meta-analysis found 6.4 NAION cases per 100,000 person-years on GLP-1 drugs.
  • FDA reviewed trial and postmarketing data; no clear mechanism identified.
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    9
    Health

    FDA requires GLP-1 drugs to warn about potential vision loss risk.

    NAION is an eye stroke that can cause sudden, permanent vision loss and has no proven treatment.

    SourcesSTAT15:56 UTCMarketWatch17:52 UTCQuartz18:50 UTCThe Independent20:20 UTCAP News20:27 UTCThe Washington Post20:50 UTCNew York Post20:51 UTCGizmodo21:46 UTCCBS News00:09 UTC
    9

    FDA requires GLP-1 drugs to warn about potential vision loss risk.

    NAION is an eye stroke that can cause sudden, permanent vision loss and has no proven treatment.
    SourcesSTAT15:56 UTCMarketWatch17:52 UTCQuartz18:50 UTCThe Independent20:20 UTCAP News20:27 UTCThe Washington Post20:50 UTCNew York Post20:51 UTCGizmodo21:46 UTCCBS News00:09 UTC