Following the U.S. Food and Drug Administration (FDA), Korea's Ministry of Food and Drug Safety has also issued a warning regarding the risk of vision loss associated with glucagon-like peptide-1 (GLP-1) class obesity and diabetes treatments.
The Ministry of Food and Drug Safety announced on the 11th that it distributed a "Drug Safety Letter" to domestic medical experts and patients, based on overseas safety information indicating that GLP-1 class drugs used for obesity treatment may increase the risk of "non-arteritic anterior ischemic optic neuropathy (NAION)."
The main content of the safety letter advises that if NAION is suspected in a patient receiving GLP-1 class drugs, medical professionals should discontinue administration and recommend immediate medical attention, while patients are instructed to consult their attending physician immediately if related symptoms appear.
GLP-1 class drugs include Mounjaro (active ingredient tirzepatide), Wegovy (active ingredient semaglutide), Saxenda (active ingredient liraglutide), and Epifex (active ingredient efpeglenatide).
In addition to distributing this safety letter, the Ministry of Food and Drug Safety requested that pharmaceutical companies supplying GLP-1 class drugs on the domestic market submit documents regarding plans for regulatory changes related to the safety information. Based on these submissions, it plans to review changes to precautions for use.
Previously, the FDA required pharmaceutical companies on the 9th (local time) to add the possibility of increased NAION risk to the "Warnings and Precautions" section of the prescribing information for all GLP-1 class treatments.
NAION occurs when blood is not sufficiently supplied to the front part of the optic nerve. Representative symptoms include a sudden drop in vision in one eye without pain, or partial obstruction of the visual field. While the fundamental cause has not yet been identified, reduced blood flow to the front part of the optic nerve can lead to permanent vision loss in some cases. It is also compared to a "stroke of the eye."
The FDA has been reviewing related safety data since 2024, when research suggesting an association between semaglutide and NAION was published. Analysis of data from 126 clinical trials involving a total of 134,253 people showed that in the GLP-1 class drug administration group, NAION occurred at a rate of 6.4 cases per 100,000 person-years. In the comparison group receiving placebo or other glucose-lowering agents, the rate was 3.8 cases. Person-years is the sum of observation periods for study subjects, where 100,000 person-years represents a scale equivalent to observing 100,000 people for one year.
However, the exact mechanism by which the drugs increase the risk of NAION has not yet been identified. Underlying conditions such as diabetes and hypertension themselves can also increase the risk of developing NAION.
in THEBIO
