Novo Nordisk faces US consolidated lawsuits over vision loss from semaglutide; shares down 70% from peak

U.S. Patients Sue Novo Nordisk Over Semaglutide-Related Vision Loss

Dozens of U.S. patients have filed a collective lawsuit against Novo Nordisk, alleging that the company's semaglutide-based drugs caused severe vision damage. The cases have been consolidated for centralized审理 in U.S. federal court.

The lawsuits come after 88 similar compensation claims were filed in Denmark. European regulators have now classified non-arteritic anterior ischemic optic neuropathy (NAION) as a "very rare" side effect of semaglutide.

Patient Accounts

Michelle Fennell, 53, began taking Ozempic for type 2 diabetes. After approximately six months, she experienced sudden heaviness in her right eye while at her desk, followed by blurred vision and reduced peripheral vision. She described the experience as "looking through a fish tank"—able to see straight ahead but with impaired vision to the right and below.

Two weeks later, Fennell was diagnosed with NAION. Her doctor immediately advised her to stop taking Ozempic to protect her other eye. She is now among the plaintiffs suing Novo Nordisk.

Jay Vandegriff, 69, started taking the drug in November 2023. During Christmas 2024, he noticed a spot in his vision, initially thinking his glasses were dirty. After cleaning them, the spot remained. He was subsequently diagnosed with NAION, resulting in vision loss affecting approximately two-thirds of his left eye.

Legal Actions

Since 2025, the law firm Weitz & Luxenberg has filed over 90 lawsuits in New Jersey state court on behalf of patients who developed NAION after taking semaglutide.

Additional cases have been filed in other federal district courts. On April 27, 2026, Edward Gillen, a Massachusetts resident, filed a lawsuit in the U.S. District Court for the Eastern District of Pennsylvania (Case No. 2:26-cv-02762). The case has been consolidated into multidistrict litigation.

Gillen's 112-page complaint states that he used Ozempic for type 2 diabetes from approximately April 2024 to May 2025, subsequently developed NAION with vision loss in both eyes, and suffered permanent physical injury, pain, emotional distress, and lost income.

Novo Nordisk's Response

Novo Nordisk maintains that existing evidence does not prove its drugs cause NAION and considers the lawsuits unfounded. Senior medical officer Tina Vilsbøll stated that the company's analysis of randomized controlled trial data found no increased risk of NAION with GLP-1 drugs, adding, "I do not see a causal relationship."

Eli Lilly stated it will continue reviewing data, including any ophthalmological concerns.

Denmark Reports 88 Claims; Europe Lists NAION as "Very Rare" Side Effect

Before the U.S. lawsuits, Denmark had already received multiple reports and compensation claims related to NAION and other adverse reactions from semaglutide use.

As of September 16, the Danish Patient Compensation Agency reported 88 claims from patients who developed NAION after using Wegovy or Ozempic. Of these:

• 27 have been approved
• 23 have been rejected
• 38 are still under review

The agency noted that numbers may change as cases continue to be processed. Approval under Denmark's compensation mechanism does not equate to a regulatory or judicial finding of medical causation.

European Regulatory Action

In June 2025, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) completed its evaluation and classified NAION as a "very rare" side effect of semaglutide.

The EMA cited multiple large epidemiological studies showing that adults with type 2 diabetes using semaglutide face approximately twice the risk of developing NAION compared to non-users, corresponding to about one additional case per 10,000 people per year.

The EMA recommended updating product information for Ozempic, Wegovy, and Rybelsus: patients experiencing sudden vision loss or rapid deterioration should seek medical attention immediately, and semaglutide should be discontinued if NAION is diagnosed.

WHO and FDA Positions

The World Health Organization (WHO) issued a safety alert in June 2025, noting that its Advisory Committee on Safety of Medicinal Products (ACSoMP) had reviewed the evidence and recommended updating semaglutide risk management plans to include NAION as a potential risk, along with further pharmacovigilance.

In July 2026, the WHO reiterated the need for ongoing post-market safety monitoring of GLP-1 drugs, stating that while they have a favorable benefit-risk profile when used under qualified medical supervision for approved indications, continued surveillance is necessary as global use increases.

As of September 19, the U.S. FDA has not added NAION warnings to GLP-1 drug labels and continues investigating the potential link. An FDA spokesperson said the agency will decide on further action after completing its evaluation, without specifying a timeline.

Financial Pressures: 74% Revenue from Semaglutide, $440 Billion Market Cap Loss

Beyond safety concerns, Novo Nordisk faces significant business challenges.

Revenue Concentration

Semaglutide products remain Novo Nordisk's core revenue driver. According to the company's 2025 annual report:

• Ozempic: 127.089 billion DKK
• Wegovy: 79.106 billion DKK
• Rybelsus: 22.093 billion DKK
• Total semaglutide sales: ~228.3 billion DKK (approximately 74% of total 309.064 billion DKK revenue)
• Year-over-year growth: ~13% from ~201.8 billion DKK in 2024

Patent Expiry Threats

According to IQVIA, the first wave of patent and data protection expirations for semaglutide in eight key markets—Canada, Brazil, China, India, Mexico, Turkey, Saudi Arabia, and South Africa—will begin in 2026. A second wave will start in select European countries, including Baltic and Central/Eastern European nations. The largest wave will follow, covering the U.S. and most of Europe.

Novo Nordisk's 2025 annual report confirms that multiple pharmaceutical companies have filed applications with the FDA to produce generic versions of Ozempic, Wegovy, and Rybelsus.

Intensifying Competition

Eli Lilly's Mounjaro and Zepbound are rapidly gaining market share. In Q3 2025, Zepbound accounted for 71% of new weight-loss drug prescriptions in the U.S., surpassing Wegovy in prescription volume.

Financial Outlook

In early 2026, Novo Nordisk projected a 5% to 13% decline in both adjusted sales and operating profit for 2026 (at constant exchange rates), citing:

• Loss of patent exclusivity in certain international markets
• Increased competition
• Lower product realization prices

Capital Markets Day

On September 21, Novo Nordisk held a "Capital Markets Day" in London, outlining plans to:

• Launch five products with blockbuster potential by 2030
• Achieve pipeline sales exceeding 150 billion DKK by 2035
• Expand oral GLP-1 production capacity
• Extend business beyond obesity and diabetes into other therapeutic areas

The company's stock closed nearly 8% lower on the day at $39.80 per share, down more than 70% from its June 2024 peak. Total market capitalization has fallen by $440 billion to $175.8 billion.

Source: National Business Daily