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TOPIC: FDA Requires Safety Labeling Changes for Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Due to Potential Increased Risk of Rare But Serious Eye Condition: FDA Safety Communication
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Ophthalmology
ISSUE: The FDA is informing patients and health care providers of a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION) associated with use of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications. NAION is a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss.
What is FDA Doing?
The agency is requiring application holders for all GLP-1 RA medications to add information to the Warnings and Precautions section of labeling about the potential increased risk of NAION associated with use of these medications.
For more information about this alert, click on the red button "Read Alert" below.
BACKGROUND: GLP-1 RAs are a class of medications (see list in Table) that mimic the effects of a natural hormone called glucagon-like peptide-1 (GLP-1) that the intestine releases. GLP-1 helps lower blood glucose (sugar) levels after eating and acts in parts of the brain that control appetite and food intake. GLP-1 RAs are widely used to treat people with type 2 diabetes or to reduce excess body weight and maintain weight reduction long term.
RECOMMENDATIONS:
Patients and Caregivers:
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Patients and caregivers should be aware of a potential increased risk of NAION, a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss, with GLP-1 RA use.
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Symptoms of NAION include sudden, painless vision loss in one eye that patients may notice upon waking; blurred or missing portions of vision (visual defects such as blind spots or tunnel vision); distortion of colors; and reduced central sharpness (e.g., blurry or hazy spots). Patients should contact their health care professional right away if they have any of these symptoms.
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If a patient has had a NAION event, they should talk with their health care professional about whether to continue taking their GLP-1 RA medication or to stop it.
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NAION is caused by decreased blood flow to the front part of the optic nerve (known as the optic disc), but the underlying cause is not completely understood. Risk factors may include smoking, diabetes, high blood pressure, sleep apnea, anemia, and kidney disease. If NAION has occurred in one eye, there is an increased risk that it will occur in the other eye.
Health Care Professionals:
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Health care professionals should be aware of the potential increased risk of rare NAION in patients treated with GLP-1 RAs.
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Instruct patients to immediately report sudden onset of acute, painless, decreased vision; visual field deficits; or other visual disturbances in one eye. If NAION is suspected, promptly refer the patient to an ophthalmologist for evaluation. Consider discontinuing the GLP-1 RA in patients who develop NAION, unless the benefits of treatment clearly outweigh the risk.
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