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FDA warns of rare vision-loss side effect from GLP-1 drugs

FDA warns of rare vision-loss side effect from GLP-1 drugs

Summary

The FDA will add a warning about rare cases of a vision-threatening condition to the labels of GLP-1 drugs used for diabetes and weight loss. The agency found a slightly higher rate among patients taking these drugs than among comparison groups, but the evidence does not establish that the drugs cause the condition.

Key Facts

  • The condition, called non-arteritic anterior ischemic optic neuropathy (NAION), involves reduced blood flow to the optic nerve and can cause lasting vision loss.
  • The warning will apply to all GLP-1 drugs, including Ozempic, Wegovy, Zepbound and Mounjaro.
  • An FDA analysis of more than 125 clinical trials found about 6 cases per 100,000 patients who took a GLP-1 drug for at least a year.
  • The FDA said the rate was fewer than 4 cases per 100,000 among people taking a placebo or other types of blood-sugar-lowering drugs.
  • Reported symptoms include blurred vision, blind spots, distorted colors and other changes in vision.
  • The FDA advised patients with vision symptoms to contact a health care professional immediately.
  • The condition also occurs in people who do not take GLP-1 drugs; the American Academy of Ophthalmology estimates 2 to 10 cases per 100,000 adults over age 50.
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