FDA orders warning for risk of eye symptoms on Ozempic, Mounjaro and other GLP-1s
The US Food and Drug Administration (FDA) has issued a new warning about GLP-1s giving users an increased risk of developing a serious eye condition.
In recent weeks, some GLP-1 users have filed lawsuits against drug manufacturers like Eli Lilly and Novo Nordisk after alleging that the likes of Wegovy and Ozempic had caused them to go blind.
Many of the complaints refer to a condition called non-arteritic anterior ischemic optic neuropathy (NAION), which can cause permanent vision loss.
"(NAION) is the most common cause of acute optic nerve injury in individuals over 50 years old," The American Academy of Ophthalmology explains. "Despite its frequency, several aspects of this disease, including its pathogenesis and effective treatments, remain unknown or unproven."
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Now, the FDA have issued a statement on the matter, saying it wants GLP-1 users to be aware of the risks that come with using the medication and the possibility of developing NAION.
What the FDA has said
It said in an announcement published November 9: "The US Food and Drug Administration 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 the FDA is doing about it
The governing body will now require that application holders for all GLP-1 RA medications add information to the 'Warnings and Precautions' section of labeling about the potential increased risk of NAION associated with use of these medications.
GLP-1 RAs explained
"GLP-1 RAs are a class of medications that mimic the effects of a natural hormone called glucagon-like peptide-1 (GLP-1) that the intestine releases," the FDA states.
"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," it explains further.
Some of the commonly-known drugs listed as GLP-1 RAs include Ozempic, Wegovy, Zepbound, and Foundayo.
What Eli Lily and Novo Nordisk have said about the GLP-1 and NAION lawsuits
In a statement to UNILAD in September, a Novo Nordisk spokesperson said: "Novo believes the personal injury lawsuits filed in the US are without merit and is vigorously defending them.
"Novo is aware of reports and epidemiological data concerning non-arteritic anterior ischaemic optic neuropathy (NAION) in patients treated with semaglutide. The available clinical, epidemiological and post-marketing data are being continuously assessed, and a causal relationship between semaglutide and NAION has not been established.
"Patient safety is a top priority for Novo and we take all reports of adverse events associated with our medicines very seriously, collaborating closely with health authorities and regulatory bodies worldwide."
Elsewhere, a spokesperson for Eli Lilly told The Boston Globe: "Patient safety is Lilly’s top priority ... we will continue to review data, including any data regarding ophthalmic issues."
UNILAD have reached out to Eli Lily and Novo Nordisk again following the FDA's recent announcement.
Niamh Shackleton
