US FDA orders new eye safety warning for Ozempic, Wegovy and other weight-loss drugs


Daijiworld Media Network - New Delhi

New Delhi, Nov 11: US health regulators have ordered a new safety warning on widely used diabetes and weight-loss medicines, including Ozempic and Wegovy, after identifying a rare eye condition that can cause severe and potentially permanent vision loss.

The US Food and Drug Administration (FDA) said the warning would be added to the labels of all glucagon-like peptide-1 (GLP-1) receptor agonist drugs, a category of medicines used to treat obesity, type 2 diabetes and other health conditions.

The warning concerns non-arteritic anterior ischemic optic neuropathy (NAION), a condition caused by reduced blood flow to the optic nerve. It can lead to sudden vision impairment and, in some cases, permanent loss of sight.

The drug category includes some of the world's best-selling medicines, such as Novo Nordisk's Ozempic and Wegovy, as well as Eli Lilly's Mounjaro and Zepbound.

The FDA began examining the potential risk after a medical study published in 2024 suggested a possible association between semaglutide, the active ingredient in Ozempic and Wegovy, and the eye disorder.

A review of more than 125 clinical trials found that NAION occurred in approximately six out of every 100,000 patients who used GLP-1 medicines for at least a year. In comparison, the incidence was fewer than four cases per 100,000 people among patients receiving a placebo or other glucose-lowering treatments.

The condition was also identified through reports submitted to the FDA's adverse event reporting system, which monitors suspected side effects and drug-related injuries.

The regulator described NAION as a rare condition but advised patients and healthcare professionals to remain alert to possible symptoms, including blurred vision, blind spots, colour distortions and other visual disturbances.

Patients experiencing sudden changes in their vision have been advised to seek immediate medical attention.

The latest warning adds to growing regulatory scrutiny of GLP-1 medicines, which have witnessed a surge in global demand because of their effectiveness in managing diabetes and promoting weight loss.

  

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Title: US FDA orders new eye safety warning for Ozempic, Wegovy and other weight-loss drugs



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