Ozempic Linked to Rare Eye Condition in New Danish Studies

Danish Health Authorities Request EU Review of Vision Loss Risk

On December 17, 2024, the Danish Medicines Agency called for a European Union investigation into Ozempic’s potential link to a rare vision-threatening condition. Two new Danish studies found that Type 2 diabetes patients using Ozempic face more than double the risk of developing non-arteritic anterior ischemic optic neuropathy (NAION) compared to those taking other diabetes medications. The research examined data from over 400,000 patients across Denmark and Norway, prompting regulatory scrutiny of the popular diabetes drug.

5 Key Points

• Danish health authorities reported 19 cases of NAION linked to Ozempic as of December 10, 2024.
• Annual NAION cases in Denmark have increased from 60 to 70 to 150 since Ozempic’s 2018 introduction.
• Studies show diabetes patients on Ozempic have twice the risk of developing NAION.
• The condition affects between 2.3 and 10.3 per 100,000 people annually in the United States
• Novo Nordisk maintains the drug’s benefit-risk profile, which remains unchanged.

Danish Studies Reveal Doubled Risk for Diabetes Patients

Two independent studies from the University of Southern Denmark examined Type 2 diabetes patients taking Ozempic compared to those on other diabetes medications. The first study analyzed data from over 400,000 diabetes patients between 2018 and 2024, with 100,000 receiving Ozempic treatment. A second study tracked more than 44,000 Danish patients and 17,000 Norwegian patients over the same period. Both studies, currently awaiting peer review on medRxiv, found that Ozempic users were more than twice as likely to develop NAION compared to patients taking other diabetes medications. The findings validate concerns first raised in a Harvard University study published in 2024.

Vision Condition Cases Rise Dramatically in Denmark

Denmark has experienced a striking increase in NAION cases since Ozempic’s market introduction in 2018. Professor Jakob Grauslund from the University of Southern Denmark’s eye diseases department reported annual cases more than doubled from the previous baseline of 60-70 cases to approximately 150 cases per year. The Danish Medicines Agency launched a dedicated six-month monitoring program to track NAION as a potential adverse effect of semaglutide, Ozempic’s active ingredient. By December 10, 2024, the agency had collected 19 specific reports linking NAION to Ozempic use, prompting their request for a European Union regulatory review.

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Novo Nordisk Responds to Safety Concerns

Danish pharmaceutical giant Novo Nordisk challenged the studies’ implications in a December 17 statement. Following what the company described as a “thorough evaluation of the studies” and internal safety assessment, Novo Nordisk maintained that “the benefit-risk profile of semaglutide remains unchanged.” The drugmaker highlighted its track record of prioritizing patient safety while defending Ozempic’s current safety profile. Market analysts, including TD Cowen’s Michael Nedelcovych, suggested the findings may have limited impact on prescriptions unless researchers prove semaglutide carries unique risks compared to other GLP-1 drugs.

Understanding NAION and Long-Term Risk Assessment

NAION attacks the optic nerve by reducing blood flow to its front portion, potentially leading to vision loss. The condition primarily affects patients over 50 years old and develops without warning signs or pain. Current U.S. data shows NAION affects between 2.3 and 10.3 patients per 100,000 people annually. The Danish researchers calculated specific long-term risk projections: diabetes patients taking Ozempic for 20 years face a 0.3% to 0.5% chance of developing NAION. Study authors characterized this as a “limited absolute magnitude” of risk. Still, they called for expanded research to determine whether Wegovy users, who take semaglutide for obesity rather than diabetes, face similar risks.