US FDA adds vision loss warning to weight-loss drugs; Ozempic, Wegovy on the list
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New Delhi, Nov 10 (IANS) US health regulators have ordered a new safety warning for widely used weight-loss and diabetes medicines, including Ozempic and Wegovy, after identifying a rare eye condition that can lead to severe and potentially permanent vision loss.
The US Food and Drug Administration (FDA) said the warning will be added to the labels of all glucagon-like peptide-1 (GLP-1) receptor agonist drugs, a class of medicines used to treat obesity, type 2 diabetes and other health conditions.
The warning relates to non-arteritic anterior ischemic optic neuropathy (NAION), a condition caused by reduced blood flow to the optic nerve.
The disorder can result in sudden vision impairment and, in some cases, permanent loss of sight.
Moreover, 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 said it began examining the issue after a medical study published in 2024 suggested a possible link 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 roughly six out of every 100,000 patients who used a GLP-1 medicine for at least a year.
By comparison, the incidence rate among patients receiving a placebo or other glucose-lowering treatments was fewer than four cases per 100,000 people.
It was also identified that reports of the condition through its adverse event reporting system, which monitors side effects and drug-related injuries.
The FDA described the condition as rare and said patients and healthcare providers should be aware of potential symptoms, including blurred vision, blind spots, colour distortions and other visual disturbances.
In addition, patients experiencing sudden changes in vision should seek medical attention immediately, according to the regulator.
The latest warning adds to growing regulatory scrutiny of GLP-1 medicines which have seen surging global demand amid their effectiveness in managing diabetes and promoting weight loss.
The US Food and Drug Administration (FDA) said the warning will be added to the labels of all glucagon-like peptide-1 (GLP-1) receptor agonist drugs, a class of medicines used to treat obesity, type 2 diabetes and other health conditions.
The warning relates to non-arteritic anterior ischemic optic neuropathy (NAION), a condition caused by reduced blood flow to the optic nerve.
The disorder can result in sudden vision impairment and, in some cases, permanent loss of sight.
Moreover, 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 said it began examining the issue after a medical study published in 2024 suggested a possible link 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 roughly six out of every 100,000 patients who used a GLP-1 medicine for at least a year.
By comparison, the incidence rate among patients receiving a placebo or other glucose-lowering treatments was fewer than four cases per 100,000 people.
It was also identified that reports of the condition through its adverse event reporting system, which monitors side effects and drug-related injuries.
The FDA described the condition as rare and said patients and healthcare providers should be aware of potential symptoms, including blurred vision, blind spots, colour distortions and other visual disturbances.
In addition, patients experiencing sudden changes in vision should seek medical attention immediately, according to the regulator.
The latest warning adds to growing regulatory scrutiny of GLP-1 medicines which have seen surging global demand amid their effectiveness in managing diabetes and promoting weight loss.
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Note: The content of this article is sourced from a news agency and has not been edited by the ap7am team.