Medical Experts Delve into Uncommon Sight Impairment Linked to Ozempic
Individuals utilizing Ozempic and similar medications may need to remain vigilant for an unanticipated side effect. Authorities in Europe are investigating if these diabetes and weight reduction treatments might elevate the chance of a seldom yet severe disorder that can result in blindness, based on recent reports suggesting a possible correlation.
On August 22, the Danish Medicines Agency declared that it would request health officials within the European Union to examine if GLP-1 medications might potentially cause non-arteritic anterior ischemic optic neuropathy, or NAION. Research undertaken this year by specialists in the U.S., and subsequently Denmark, has proposed that GLP-1 users might face an enhanced risk of NAION. At this juncture, however, it hasn't been ascertained whether there's a causative connection between the two, and the disorder appears to be extremely uncommon even among GLP-1 users.
NAION is triggered by reduced blood flow to the optic nerve, subsequently causing sudden and often permanent vision loss. Despite minimal knowledge regarding why it occurs, some potential risk factors include age, high blood pressure, and sleep apnea.
Medical professionals at Harvard Medical School and Mass Eye and Ear were the first to openly recognize the potential link between NAION and GLP-1s. In July, they published a study demonstrating that subjects taking semaglutide (the active component in Ozempic and Wegovy) to manage their diabetes or obesity were more likely to develop NAION than similar patients using other medications over a three-year period.
During the month of October, two separate research teams at the University of Southern Denmark ** released the preliminary results of their investigations on the topic (one study is slated for publication in a peer-reviewed journal, while the other** is undergoing peer review). Both studies assessed the frequency of NAION amongst individuals in Denmark taking semaglutide for diabetes compared to other medications (one study additionally looked at residents in Norway). Similar to the earlier U.S. study, they discovered a conspicuously higher risk of NAION in those using semaglutide.
The Danish Medicines Agency has also been tracking a potential upswing in NAION cases, by analyzing adverse event reports submitted to it by medical professionals and patients (most countries, including the U.S., employ a comparable system). However, it wasn't until these latest studies that the agency deemed it crucial to escalate matters. It is now requesting the EU's Pharmacovigilance Risk Assessment Committee (PRAC) to evaluate the Danish studies and additional data to determine if NAION is a genuine side effect of semaglutide use.
“Since June, we have examined reports and studies concerning the severe eye condition referred to as NAION in cooperation with our European counterparts. These extensive data from Danish and Norwegian sources may now serve as the basis for assessment by the European Pharmacovigilance Risk Assessment Committee,” stated Line Michan, director of pharmacovigilance at the DMA, in a statement on August 22. “As a result, we will now urge PRAC to appraise the latest studies.”
Although these studies lend more credence to the notion that GLP-1 medications can instigate NAION, they remain far from unquestionable evidence. Observational, retrospective data alone cannot verify a cause-and-effect relationship between any two factors. Other forms of investigations, such as placebo-controlled clinical trials, real-life studies of GLP-1 users, or even animal lab studies, would likely be necessary to confirm a genuine increased risk of NAION from these medications.
Researchers and health officials have also made it a point to mention that any such heightened risk would likely be incredibly small. Though NAION is the second most common cause of blindness due to optic nerve damage, following glaucoma, it's a rare affliction. In the U.S., it's estimated that approximately thousands of new cases of NAION emerge every year.
The earlier U.S. study found that semaglutide was associated with a sevenfold greater risk of NAION. However, the larger, probably more representative Danish studies instead discovered a two- to threefold higher risk. The Danish researchers estimated that for every 10,000 individuals treated with semaglutide annually, around 1.5 to 2.5 additional cases of NAION might materialize (under the assumption of a genuine association, naturally). Up until December 2023, the DMA has received 19 reports of NAION possibly connected to semaglutide, which date back to July 2021.
The advantages of GLP-1 treatment are highly likely to outweigh the potential hazard of NAION for the majority of eligible candidates. Untreated diabetes can itself lead to visual difficulties, for example. Nevertheless, considering how serious and life-altering NAION can be, even a small enhanced risk of it warrants close attention. By exploring this link further, it's conceivable that researchers will discover additional factors that influence a person's likelihood of developing NAION while taking a GLP-1 medication, which could potentially help prevent cases in the future. Someone at an elevated risk might be counseled to opt for a different diabetes medication, for instance. For now, we'll simply have to wait and see what unfolds.
GLP-1 drugs like Ozempic are known to trigger common side effects such as nausea and constipation, although these often subside over time. In its widespread release to the public, the drugs have been associated with significant, yet infrequent complications like gastroparesis (stomach paralysis). Some research has also flagged potential drawbacks of their use that haven't been substantiated by subsequent studies, such as a greater risk of suicide.
In light of the ongoing investigations, it's crucial for scientists to explore potential risk factors associated with GLP-1 medications and their impact on health. As technology and science advance, so too does our ability to develop sophisticated treatments like GLP-1 drugs, but it's equally important to ensure their safety and minimize any potential negative side effects.
In the future, researchers may identify specific patient populations that are more susceptible to NAION when taking GLP-1 medications, allowing for personalized treatment approaches to minimize risk. By prioritizing both the benefits and potential drawbacks of these medications, we can strive to optimize patient care and improve health outcomes.
