Side Effects Blog

From that November 2026 FDA document, “FDA Requires Safety Labeling Changes for Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Due to Potential Increased Risk of Rare But Serious Eye Condition“, regarding the significance of this increased risk NAION label change:

Patients and caregivers should be aware of a potential increased risk of NAION, a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss, with GLP-1 RA use.

Symptoms of NAION include sudden, painless vision loss in one eye that patients may notice upon waking; blurred or missing portions of vision (visual defects such as blind spots or tunnel vision); distortion of colors; and reduced central sharpness (e.g., blurry or hazy spots). Patients should contact their health care professional right away if they have any of these symptoms.

If a patient has had a NAION event, they should talk with their health care professional about whether to continue taking their GLP-1 RA medication or to stop it.

Before and after this increased risk NAION label change, we are investigating possible drug injury lawsuits for people diagnosed with NAION while using Ozempic, Wegovy, or Rybelsus — all of which are semaglutide-containing drugs — as well as people who were using Zepbound or Mounjaro — both of which are tirzepatide-containing drugs.

Coincidentally, our last Drug Injury Watch article on this NAION side-effect drug safety issue was published on October 16, 2026: “Vision Loss Associated With Ozempic, Mounjaro, And Other GLP-1 Drugs – People With Vision Loss Want Warnings Even If Risk Of NAION Eye Injury Is Low“.

For people diagnosed with NAION while using Ozempic, Wegovy, or Rybelsus, as well as people diagnosed with NAION while using Zepbound or Mounjaro, we provide possible drug injury lawsuit evaluations that are free, confidential, and without any obligation (that is, no strings attached):

Ozempic / Wegovy / Rybelsus Vision Loss Case Evaluation Form

Zepbound / Mounjaro Eye Side Effect NAION Case Evaluation Form

Two other ways to get an evaluation of a possible NAION drug injury lawsuit are to email lawyer Tom Lamb at TJL@LambLawOffice.com or call our office at 910-256-2971.

Of course, we are looking to see the legal ramifications of this increased risk NAION label change ordered by the FDA in November 2026 for those drug injury lawsuits already filed for people diagnosed with NAION while using Ozempic, Wegovy, or Rybelsus, as well as Zepbound or Mounjaro.

And to be clear, we remain interested in investigating new cases for people diagnosed with NAION while using Ozempic, Zepbound, etc. after this November 2026 increased risk NAION label change.

Andexxa (andexanet) was recalled by AstraZeneca from the US market in December 2025.

Andexxa was given to patients using Eliquis (apixaban) or Xarelto (rivaroxaban) when they had an urgent need for the reversal of those anticoagulation drugs. Specifically, Andexxa was ordered by doctors in life-threatening or uncontrolled bleeding medical emergencies.

Following reports of patients given Andexxa developing a deep vein thrombosis (DVT), a pulmonary embolism (PE), or another serious blood-clot medical condition, the FDA started a drug safety investigation. The issue was whether there was an apparent increased rate of Andexxa-related blood clots, which can lead to DVT and/or PE, as well as clotting-related deaths, compared with other means to reverse anticoagulation.

Our law firm is investigating possible Andexxa lawsuits involving a pulmonary embolism (PE), deep vein thrombosis (DVT), or another serious blood-clot medical condition after a person was given Andexxa to reverse anticoagulation.

These Andexxa lawsuits would be filed against AstraZeneca, the pharmaceutical company responsible for Andexxa here in the US.

We point out that the doctors who ordered Andexxa would not be named as Defendants in these Andexxa lawsuits because the Andexxa drug label did not have any warnings about an increased risk of Andexxa-related blood clots, which can lead to DVT and/or PE, as well as clotting-related deaths.

As background, here are some earlier Drug Injury Law articles relevant to the Andexxa lawsuits:

• Andexxa Blood Clots and Clotting-Related Deaths: FDA November 2024
• Andexxa Blood Clot Cases Before Any AstraZeneca Drug Recall
• Andexxa Blood Clot Drug Injury Lawsuits

If you think you might have an Andexxa lawsuit against AstraZeneca, we encourage you to submit an Andexxa Blood Clots Case Evaluation Form online. Or call drug injury lawyer Tom Lamb at 910-256-2971 to discuss your Andexxa case.

Before we point out two recent medical news articles relevant to NAION with Ozempic, Wegovy, Mounjaro, or Zepbound use, and whether their respective drug labels should have NAION and vision loss warnings, here are a couple of earlier pieces we wrote about those issues:

NAION Linked To Zepbound, Mounjaro, Ozempic, Wegovy: 2026 News Update (5/22/26)

Ozempic Eye Side Effect NAION Warnings Update July 2026 (7/28/26)

Now for the two recent medical news articles about NAION with Ozempic, Wegovy, Mounjaro, or Zepbound use, as well as the present lack of any NAION and vision loss warnings here in the US:

1. “GLP-1s may be linked to vision loss, but overall risk ‘very, very low’“, published online October 2, 2026, by Healio Primary Care Optometry News; and
2. “GLP-1s and NAION: Do Patients Need a Warning?“, published online October 2, 2026, by Medscape Medical News.

From talking to numerous people who have vision loss due to NAION diagnosed while using Ozempic and Wegovy (which are both semaglutide-containing drugs), as well as Mounjaro and Zepbound (which are both tirzepatide-containing drugs), we can tell you that many of these people said they were disappointed there were no NAION and vision loss warnings. Moreover, some of those people were understandably angry about this failure by the responsible drug companies.

We have been investigating drug injury lawsuits against those drug companies for patients who have vision loss due to NAION with Ozempic, Wegovy, Mounjaro, or Zepbound use.

If you have been diagnosed with NAION due to Ozempic, Wegovy, Mounjaro, or Zepbound use, you may want to submit a Case Evaluation Form online to get a free review of your potential NAION lawsuit:

Ozempic / Wegovy / Rybelsus Vision Loss Case Evaluation Form

Zepbound / Mounjaro Eye Side Effect NAION Case Evaluation Form

If you would prefer to discuss your potential NAION lawsuit with drug injury lawyer Tom Lamb, send him an email at TJL@LambLawOffice.com or call 910-256-2971.

We begin with a September 21, 2026 NBC News report (video), “Hundreds of lawsuits filed against some GLP-1 Makers over vision loss“.

And from among the many newspaper articles about these vision loss lawsuits, we get the following from a September 18, 2026 article published by the Wall Street Journal, “Patients Sue GLP-1 Drugmakers Over Risk of Sudden Vision Loss“:

Michelle Fennell was sitting at her desk when her right eye started feeling heavy. Suddenly, it was blurry and her peripheral vision waned. It felt like she was looking through a fishbowl; she could see straight ahead but not to her right or down.

Two weeks later, a doctor diagnosed Fennell, 53 years old, with nonarteritic anterior ischemic optic neuropathy, or NAION, a condition that leads to sudden, often permanent vision loss.

The doctor asked what medicines she was taking. “He said right away, stop taking Ozempic,” to protect her remaining vision, said Fennell, who started taking the drug to treat her Type 2 diabetes six months prior. “I was shocked.”…

Fennell is one of dozens of people suing Novo, maker of the popular weight-loss and diabetes drugs Wegovy and Ozempic, claiming the medication caused this side effect

As background, to better understand what is behind this increase in vision loss lawsuit filings:

• The active ingredient semaglutide has been linked to NAION; Ozempic as well as Wegovy are semaglutide-containing drugs.
• The active ingredient tirzepatide has been linked to NAION; Mounjaro as well as Zepbound are tirzepatide-containing drugs.
• NAION is sometimes called an “eye stroke,” and it occurs when the optic nerve does not receive enough blood flow.
• NAION typically causes sudden vision loss and, in severe cases, can lead to blindness.
• There are currently no proven treatments for NAION.
• As of today (September 23, 2026), the drug labels for Ozempic, Wegovy, Mounjaro, and Zepbound do not include warnings about the NAION eye-related side effect of these medications and other GLP-1 drugs.
• Based on this failure to warn about NAION and the vision loss resulting from this serious side effect, NAION drug injury lawsuits have been filed against the responsible pharmaceutical companies seeking legal compensation for patients diagnosed with NAION and suffering vision loss.

Long before these 2026 newspaper articles and TV news reports about the vision loss lawsuit filings increase — since back in the summer of 2024 — we have been investigating drug injury lawsuits for patients who used Ozempic, Wegovy, Mounjaro, or Zepbound and have been diagnosed with NAION, or an “eye stroke”.

These NAION vision loss lawsuits for patients using Ozempic or Wegovy would be filed against Novo Nordisk, which last week announced it had shortened its name to “Novo”. For more, see our Drug Injury Law information page for this set of vision loss lawsuits: Eye-related Side Effects of Ozempic, Wegovy, and Rybelsus With Vision Loss.

Drug injury NAION vision loss lawsuits involving Mounjaro or Zepbound for patients with vision loss would be filed against Eli Lilly. For more about this set of vision loss lawsuits: Zepbound and Mounjaro Eye Side Effect NAION Information Page

For these vision loss lawsuits, we offer an online case evaluation service that is free and confidential, and without obligation:

Ozempic / Wegovy / Rybelsus Vision Loss Case Evaluation Form

Zepbound / Mounjaro Eye Side Effect NAION Case Evaluation Form

Experienced drug injury attorney Tom Lamb reviews each one of these online Case Evaluation Form submissions. Or call him at 910-256-2971 to discuss a possible NAION vision loss lawsuit.

The medical journal Arthritis & Rheumatology published this article about Tavneos (avacopan) in August 2026, “Hepatotoxicity of Avacopan: Real-World Incidence and Confirmed Cases of Severe Drug-Induced Liver Injury in a US National Rheumatology Registry”.

The following information about the Tavneos liver injury findings of that recent Arthritis & Rheumatology medical journal report on Tavneos liver risks comes from this August 24, 2026, MedPage Today article, “U.S. Registry Data Confirm Liver Risk With Controversial Vasculitis Drug“:

The new report is likely to bolster concerns about hepatotoxicity, insofar as it involves patients receiving the drug in routine practice, based on relatively systematic data collected in the American College of Rheumatology’s RISE registry. More than 1,000 U.S. rheumatology practices contribute to RISE — about 25% of the total — covering an estimated 3.5 million patients. Roberts and colleagues searched RISE for patients with at least one recorded prescription for [Tavneos (avacopan)] from October 2021 to March 2025, along with an [autoantibody (ANCA)-associated vasculitis (AAV)] diagnosis as indicated by ICD-9/10 codes, coming up with 238.

Liver enzyme elevations were identified mostly using the FDA’s standard definitions: three times the upper limit of normal for aspartate and alanine aminotransferase and twice the upper limit of normal for alkaline phosphatase. The FDA also considers elevations in bilirubin as an important marker, but has not specified a threshold; therefore, the study authors defined it as >2 mg/dL, which is twice the upper limit of normal at most clinical labs, they said.

Patients having at least two enzymes elevated were then evaluated for [drug-induced liver injury (DILI)], which involved contacting their treating clinicians to obtain more detailed information….

These Tavneos legal compensation cases would be filed as drug injury lawsuits against Amgen, alleging that the pharmaceutical company failed to warn about these Tavneos liver side effects.

People interested in learning more about Tavneos legal compensation cases can contact drug injury lawyer Tom Lamb at TJL@LambLawOffice.com or 910-256-2971.

In addition, they can submit a Drug Injury Case Evaluation Form online to have their matter reviewed as a potential Tavneos drug injury lawsuit.

In December 2025, all the federal NAION cases filed in courts were consolidated by the U.S. Judicial Panel on Multidistrict Litigation (JPML). This JPML ruling appointed U.S. District Judge Karen S. Marston, in the Eastern District of Pennsylvania, to preside over this consolidated federal court NAION litigation: MDL-3163 IN RE: Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy Products Liability Litigation.

There are additional NAION cases filed in courts around the country on behalf of people seeking legal compensation for vision loss. Those NAION lawsuits are pending in numerous different state courts.

The NAION vision loss cases in each of those courts involve, for the most part, these popular drugs used for diabetes or weight loss: Ozempic, Wegovy, Rybelsus, Mounjaro, and Zepbound.

We have been reporting on the medical and legal developments pertinent to these NAION cases filed in courts for more than two years, since July 2024.

Here is a list of some past relevant Drug Injury Law articles you may want to read for background information:

• Ozempic Eye Side Effect NAION Warnings Update July 2026
• Semaglutide NAION Lawsuits in 2026 for Wegovy, Rybelsus, Ozempic Vision Loss
• NAION Linked To Zepbound Mounjaro, Ozempic, Wegovy: 2026 News Update
• Ozempic and Wegovy NAION Study 2026 Report: Two New Findings
• Ozempic-NAION Warnings Should Be In January 2026 Drug Label For New Pill Version
• Ozempic NAION Risk 200% Higher Than Some Other Diabetes Drugs
• Mounjaro and Ozempic NAION Vision Loss Lawsuits: Federal Court MDL No. 3163
• Ozempic and Mounjaro Increased Risk of NAION More Than Other Diabetes Drugs

More vision loss cases are being investigated, so there will be more NAION cases filed in courts during 2026 and the next couple of years.

People diagnosed with NAION who suffered vision loss while using Ozempic, Wegovy, Rybelsus, Mounjaro, and Zepbound can submit an online Case Evaluation Form to be reviewed by drug injury lawyer Tom Lamb:

Ozempic / Wegovy / Rybelsus Vision Loss Case Evaluation Form

Zepbound / Mounjaro Eye Side Effect NAION Case Evaluation Form

Or, if you prefer, call 910-256-2971 to speak directly to attorney Tom Lamb about a possible Ozempic, Wegovy, Rybelsus, Mounjaro, or Zepbound vision-loss legal compensation case involving NAION.

Further, in that July 2026 TGA Medicines Safety Update where the Ozempic NAION risk is highlighted, one finds a list of earlier actions taken by some other international drug regulators:

• • United Kingdom: MHRA drug safety update: Semaglutide (Wegovy, Ozempic and Rybelsus): risk of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

• • European Union nations: EMA News: PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy

• • World Health Organization member countries: WHO News: The use of semaglutide medicines and risk of non-arteritic anterior ischemic optic neuropathy (NAION)

However, the current (Revised: 5/2026 version) Ozempic Prescribing Information, or drug label, in the United States still does not include warnings about Ozempic-related eye side effects, such as NAION.

Drug injury lawsuits involving Ozempic for patients with vision loss due to NAION are being filed in the US against Novo Nordisk for its failure to include Ozempic eye side effect NAION warnings.

We emphasize that because there are no warnings in the current Ozempic drug label about an increased risk of NAION, those Ozempic lawsuits are not being filed against the doctors who prescribed Ozempic to the people who have suffered vision loss due to this serious eye-related side effect.

People diagnosed with NAION can submit an Ozempic Vision Loss Case Evaluation Form online. Or, if you prefer, call 910-256-2971 to talk with drug injury lawyer Tom Lamb about a possible Ozempic NAION lawsuit.

Read the article in full at Drug Injury Watch]

From the Abstract for this recent PLOS Medicine medical journal article relevant to Wegovy, Rybelsus, and Ozempic NAION vision loss cases:

Conclusions: Our findings suggest a possible association between semaglutide use and an increased risk of NAION in patients with [type 2 diabetes (T2DM)]. Although the absolute risk is low, clinicians should be aware of this potential adverse event, particularly in individuals at increased baseline risk for optic neuropathies. While these findings support current recommendations to discontinue semaglutide in patients diagnosed with NAION, the certainty of the available evidence is low, underscoring the need for further high-quality studies to clarify this association.

However, as we pointed out above, the current drug labels for Ozempic, Wegovy, and Rybelsus do not have any warning about semaglutide-associated NAION vision loss or blindness as a possible side effect. As seen by this list of earlier Drug Injury Law articles, our law firm is very familiar with the semaglutide-associated NAION side effects of Ozempic, Wegovy, and Rybelsus:

• Ozempic and Wegovy NAION Study 2026 Report: Two New Findings
• Ozempic-NAION Warnings Should Be In January 2026 Drug Label For New Pill Version
• Ozempic NAION Risk 200% Higher Than Some Other Diabetes Drugs
• Ozempic Vision Loss Claims Compensation Payments Made in 2025
• Ozempic NAION Rate Higher in Recent 2025 Medical Study
• Link Between Ozempic and NAION Also Involves the Eye Disorder AION
• Ozempic Blindness Legal Cases Filed Against Novo Nordisk in April 2025
• Vision Loss Linked to Ozempic and Rybelsus Use by Diabetes Patients
• Ozempic Eye Problems Caused by Semaglutide-Related NAION
• Ozempic Linked to Vision Loss With Increased Risk of NAION Side Effect
• Ozempic Side Effects Include Eye Problems With Possible Vision Loss

In addition, our law firm has experience handling semaglutide NAION lawsuits involving Wegovy, Rybelsus, and Ozempic vision loss or blindness cases for patients.

Patients diagnosed with NAION-related vision loss or blindness can submit an Ozempic/Wegovy/Rybelsus Vision Loss Case Evaluation Form online. Or, if you prefer, call 910-256-2971 to talk with drug injury lawyer Tom Lamb about semaglutide NAION lawsuits.

When all was said and done, the authors of this 2026 medical study report about NAION concluded:

In this large cohort study, [Zepbound, Mounjaro, Ozempic, Wegovy, and other GLP-1RA drugs] use was associated with a modestly increased risk of NAION compared with [sodium-glucose cotransporter-2 inhibitors (SGLT2i) drugs] use. While the absolute risk remains low, the specificity of this finding may warrant heightened vigilance.

NAION linked to Zepbound, Mounjaro, Ozempic, Wegovy, and other GLP-1RA drugs is an issue that first came to light in the second part of 2024. For example, two large medical studies from Denmark found that people who used Ozempic had double the risk of developing NAION, which can cause vision loss and blindness.

In the past couple of years, NAION drug injury lawsuits involving Zepbound, Mounjaro, Ozempic, Wegovy, and other GLP-1RA drugs have been filed against the responsible pharmaceutical companies for their failure to warn patients and doctors about the risk of developing NAION. For an introduction to the medical and legal aspects of these NAION drug injury lawsuits, here are two relevant Drug Injury Law website links:

• Eye-related Side Effects of Ozempic, Wegovy, and Rybelsus With Vision Loss
• Zepbound and Mounjaro Eye Side Effect NAION Information Page

We are investigating cases of NAION linked to Zepbound, Mounjaro, Ozempic, Wegovy, and other GLP-1RA drugs for patients as drug injury lawsuits seeking legal compensation for their vision loss. We point out that those NAION lawsuits would not be filed against the patients’ doctors because the pharmaceutical company failed to warn about the NAION eye side effect associated with their drug.

Amgen has taken steps to update its Tavneos label amid an ongoing battle with the FDA. The company filed a supplement on Wednesday that would add more information to the warning label about post-market cases of vanishing bile duct syndrome (VBDS), a serious liver complication that can lead to death. The supplement, disclosed in Amgen’s first-quarter earnings release, marks another twist in the company’s ongoing saga with regulators over Tavneos’ future on the market…. The FDA asked Amgen to pull Tavneos from the market voluntarily at the beginning of this year. [The FDA’s Center for Drug Evaluation and Research (CDER)] reiterated its push in a proposal to withdraw the drug earlier this week, citing new information that it says suggests Tavneos “has not shown to be effective for its approved use,” and that its marketing application held “untrue statements of material fact.” The FDA accused study personnel of manipulating the results of a pivotal clinical trial used to approve the drug. Regulators also said they were “increasingly concerned” about the drug’s safety.

To understand the context in which Amgen proposed a Tavneos label change that adds vanishing bile duct syndrome warnings by means of its April 29, 2026, filing with the FDA, we point out this excerpt from this April 27, 2026, FDA Drug Alerts and Statements document, “CDER proposes to withdraw approval of TAVNEOS“:

Additionally, CDER is increasingly concerned about the safety profile of TAVNEOS. As further detailed in a March 31, 2026, drug safety communication, CDER has identified cases of serious drug-induced liver injury (DILI) associated with TAVNEOS. Some cases involved vanishing bile duct syndrome (VBDS), which is characterized by progressive destruction and disappearance of the bile ducts in the liver. Although hepatotoxicity is a serious adverse reaction for TAVNEOS identified in premarket clinical trials and described in product labeling, VBDS and DILI cases with fatal outcomes represent new safety concerns.

Here are two recent Drug Injury Watch articles relevant to the Tavneos label change that adds vanishing bile duct syndrome warnings, as well as the possible FDA Tavneos drug recall:

• Tavneos Liver Injury Drug Safety Communication Issued by FDA in Late March 2026 (March 31, 2026)
• Tavneos Lawsuits for Drug Injury After Possible Tavneos Recall (April 17, 2026)

Even before this Tavneos label change that adds more liver side effects in April 2026, we have been investigating possible drug injury lawsuits involving patients diagnosed with Tavneos-related vanishing bile duct syndrome (VBDS) or Tavneos drug-induced liver injury (DILI).

If you or someone you know was diagnosed with the VBDS or DILI Tavneos liver side effects, you can submit a Drug Injury Case Evaluation Form online, email lawyer Tom Lamb at TJL@LambLawOffice.com, or call him at 910-256-2971.