Danish researchers are concerned about the use of Ozempic, a widely prescribed diabetes drug, after finding it significantly increases patients’ risk of suffering what doctors describe as an “optic nerve stroke.” “.
A risk twice as great
The results of the study, published in theInternational Journal of Retina and Vitreoussuggest that taking Ozempic (semaglutide) more than doubles the risk of developing non-arteritic anterior ischemic optic neuropathy (NAION), a serious eye condition characterized by sudden loss of vision in one eye, due to Inadequate blood circulation in the optic nerve. NAION is considered the most common cause of sudden vision loss in people over the age of 50.
“We can reasonably consider that it is a vascular accident of the optic nerve,” he told Epoch Times Dr. Joseph Rizzo III, professor of ophthalmology and director of neuro-ophthalmology at Harvard Medical School (Massachusetts Eye and Ear). “And, like a stroke, function is lost.”
The symptoms of NAION include:
• Sudden loss of vision: it usually occurs when you wake up in the morning or after a nap.
• Painless loss of vision: Unlike other eye conditions, NAION is usually painless.
• Loss of vision in one eye: It usually affects only one eye, but can sometimes affect both eyes.
• Blurred vision: Vision may be blurred or distorted, especially in the lower half of the visual field.
• Loss of color vision: some people may experience loss of color perception or see colors differently.
• Shadow in the visual field: some patients may see a dark shadow or blind spot in their field of vision.
Researchers examined data from 424,152 Danish patients with type 2 diabetes to study the link between Ozempic and increased risk of NAION. The results indicate that Ozempic significantly increases the risk of developing this debilitating disease.
“We found that Ozempic more than doubles the risk of developing NAION,” Jakob Grauslund, professor of ophthalmology at the Department of Clinical Research at the University of Southern Denmark, said in a statement. “This is a condition that can cause serious and permanent vision loss.”
Increase in NAION cases since the introduction of Ozempic
There has been a marked increase in NAION cases since the introduction of Ozempic in Denmark in 2018, according to Professor Grauslund.
“Where we used to see between 60 and 70 cases of NAION a year, we now see up to 150,” he said, noting that the majority of hospital admissions for NAION are for now patients with type 2 diabetes.
Similarly, in a related preliminary study that has not yet been peer-reviewed, Anton Pottegard, professor of pharmaceuticals at the Department of Public Health at the University of Southern Denmark (SDU), and his team examined new users of Ozempic among patients with type 2 diabetes in Denmark and Norway. Consistent with Professor Grauslund’s findings, Professor Pottegard’s team reported that the risk of developing NAION doubles with taking Ozempic.
Although the current studies found a lower number of cases than an earlier US study – which showed the risk more than doubled – the two Danish studies support a similar risk for diabetic patients taking Ozempic.
-In a statement sent by email, Professor Pottegard indicated to Epoch Times that these studies will likely trigger “a number” of new regulatory and research actions.
“Regulators have now begun a process of evaluating studies to decide whether NAION should be officially recognized as a side effect of Ozempic,” he wrote. “We do not know (yet) whether this is a class effect, i.e. one that also affects the use of tirzepatide and other upcoming new drugs, or whether it has an effect specific to semaglutide.
According to Professor Pottegard, the results of the new study will “undoubtedly be the subject of further research” and, in the event that regulators recognize the risk, they could set up monitoring programs for other drugs in this category. class.
“Moreover, there is certainly a need for research not only into the reasons for this phenomenon (we have no idea of the mechanism), but also into the patients who are at risk of experiencing it,” he said. -he writes.
The results do not mean stopping treatment with Ozempic
Despite these results, Danish researchers cautioned against immediately stopping treatment with Ozempic.
“This is a serious but very rare side effect. Often we only learn about this kind of thing after a new drug has been on the market for a few years,” Professor Pottegard said in his statement. “It should be emphasized that this effect is neither more serious nor more common than the rare side effects of many other drugs that we continue to use.”
Furthermore, Kurt Hojlund, professor of diabetology, stressed in the press release the importance of treating type 2 diabetes taking into account the risks associated with Ozempic.
“Treating type 2 diabetes is extremely important, but the question is whether the small increased risk of severe vision loss from using Ozempic means one of the others should be used instead. new drugs that protect against kidney and cardiovascular diseases,” he said.
Response from Novo Nordisk
In a statement sent by email to Epoch TimesNovo Nordisk stated that NAION is a very rare eye disease but is not an adverse effect for marketed formulations of semaglutide (Ozempic, Rybelsus and Wegovy).
“After a thorough evaluation of the studies and Novo Nordisk’s internal safety assessment, Novo Nordisk is of the opinion that the benefit-risk profile of semaglutide remains unchanged,” a company spokesperson wrote.
The Novo Nordisk spokesperson said that while both studies showed a doubling of relative risk, the absolute risk and absolute number of people affected is very low.
“This corresponds to the very low annual incidence of this rare disease. One of the studies found that two people in 10,000 patients treated with semaglutide over the course of a year developed NAION, compared to 1 in 10,000 in the comparison group, suggesting that the absolute risk is very low. “, wrote the Novo Nordisk spokesperson, adding that studies have not demonstrated a cause and effect relationship between semaglutide and NAION.
“Novo Nordisk, for its part, performed an analysis of randomized controlled clinical trials of GLP-1 receptor agonists, including blinded evaluation by an ophthalmologist to confirm NAION diagnoses. This analysis made it possible to identify very few cases of NAION confirmed by an ophthalmologist, without an imbalance in favor of Novo Nordisk’s GLP-1 receptor agonists.
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