Here’s What You Need To Know About the FDA’s New GLP-1 Warning

Here's What You Need To Know About the FDA's New GLP-1 Warning

The American Academy of Ophthalmology and the North American Neuro-Ophthalmology Society respond to the FDA's decision to inform patients and health care providers of a potential increased risk of vision loss associated GLP-1 medications<_o3a_p>

SAN FRANCISCO - The Food and Drug Administration (FDA) this week announced that it is requiring manufacturers of GLP-1 medications to warn that they can increase the risk of vision loss. The warning applies to all GLP-1 medications, including popular weight loss drugs like Ozempic and Wegovy.

The American Academy of Ophthalmology and the North American Neuro-Ophthalmology Society (NANOS) are advising patients to not panic. The warning is new, but our guidance is unchanged: NAION is rare, any added risk appears small, and it has not been established that these medications cause NAION. Patients should not stop taking the medication without talking to their doctor first.

"We welcome the FDA's careful review, which is consistent with what the Academy and NANOS concluded earlier this year in a published review: NAION is rare, any added risk appears small, and it has not been established that these medications cause NAION," said Peter A. Quiros, MD, a neuro-ophthalmologist and clinical spokesperson for the Academy. "GLP-1 medications offer important benefits for people with diabetes, obesity, and heart disease, so our message to patients is simple. Don't stop your medication without talking to your doctor, and if you notice sudden, painless vision loss in one eye, see an ophthalmologist promptly."

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 happens when the optic nerve does not get enough blood flow, causing sudden, painless loss of vision in one eye.

The FDA has applied the labeling change across the GLP-1 RA class. Most published studies on NAION have focused on semaglutide. Data for individual GLP-1 RA medications other than semaglutide remain more limited, and whether any association differs among individual agents or patient populations remains uncertain.

For patients who develop NAION while taking a GLP-1 RA medication, the FDA recommends considering discontinuation unless the benefits of treatment clearly outweigh the risk. This approach aligns with the joint Academy/NANOS recommendation for individualized, shared decision-making.

GLP-1 RA medications can provide important benefits for patients with diabetes, obesity, and cardiovascular disease, and the benefits and risks of stopping treatment may differ substantially from patient to patient. The decision to continue or discontinue treatment should therefore be made with the patient's care team, taking into account the indication for treatment, overall health, alternative therapeutic options, and the potential risk to the fellow eye.

The Academy and NANOS offer the following guidance to patients, given that the FDA has decided to require labeling changes for all GLP-1 RA medications:

• Patients should not stop a GLP-1 RA medication on their own because of the FDA announcement. Any decision about continuing or discontinuing treatment should be discussed with the prescribing clinician.
• Patients who experience sudden, painless decreased vision, loss of part of their visual field, or other sudden visual changes in one eye should seek prompt evaluation by an ophthalmologist.
• If NAION is diagnosed, the patient, ophthalmologist, and prescribing clinician should work together to weigh the potential ocular risk against the benefits of continued GLP-1 RA therapy.
• Patients with a history of NAION should discuss the potential risk to the fellow eye with their physicians when considering GLP-1 RA therapy.
• Routine eye examinations solely to assess NAION risk before starting a GLP-1 RA medication are not recommended based on current evidence. Patients with diabetes should continue their regularly scheduled diabetic eye examinations.

The Academy and NANOS continue to review emerging evidence regarding GLP-1 RA medications and NAION and will update their guidance as additional data become available. Keeping physicians and patients up-to-date on the best currently available evidence and consensus expert guidance is our top priority.

This month, the Academy published a clinical statement evaluating whether GLP-1 RA medications worsen vision in patients who have diabetic retinopathy. Access the statement here. This clinical statement concludes that the currently available evidence does not consistently demonstrate that GLP-1 RA treatment is associated with worsening of diabetic retinopathy.

About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world's largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, we protect sight and empower lives by setting the standards for ophthalmic education and advocating for our patients and the public. We innovate and support research to advance our profession and to ensure the delivery of the highest-quality eye care. Our EyeSmart® program provides the public with the most trusted information about eye health. For more information, visit aao.org.

About the North American Neuro-Ophthalmology Society
The North American Neuro-Ophthalmology Society (NANOS) is a professional organization of about 700 members who are fully trained ophthalmologists or neurologists. NANOS is dedicated to achieving inclusive excellence in the care of patients with neuro-ophthalmic diseases by the support and promotion of equitable education, research, and the practice of Neuro-Ophthalmology. Visit our official website to learn more.<_o3a_p>