Side Effects Blog

Anterior ischemic optic neuropathy (AION) results from ischemic damage to the anterior portion of the optic nerve, a region primarily supplied by the posterior ciliary artery circulation. Anterior ischemic optic neuropathy is divided into two types: arteritic AION (AAION), secondary to vasculitis (especially giant cell arteritis), and nonarteritic AION (NAION), secondary to non-inflammatory small vessel disease. NAION constitutes 95% of all AION and is the most common cause of acute optic neuropathy in people over the age of 50…. [Footnotes omitted.]

Given this relationship between NAION and AION, we should keep in mind that a person using Rybelsus, Wegovy, or Ozempic diagnosed with AION might have NAION as a side effect of their semaglutide-containing drug.

In turn, a person diagnosed with AION while using Ozempic, Wegovy, or Rybelsus could have a potential drug injury lawsuit to file against Novo Nordisk, the responsible pharmaceutical company, even though there was no specific mention of NAION by their eye doctor.

More information about these NAION lawsuits against the drug company is outlined in our prior article, “Ozempic Blindness Legal Cases Filed Against Novo Nordisk in April 2025“.

If you have been diagnosed with AION or NAION, we can assist you with a possible drug injury lawsuit that would be filed against Novo Nordisk, the responsible pharmaceutical company. To get started, you can complete our online Case Evaluation Form, or you can call attorney Tom Lamb (910-256-2971) to discuss your possible case.

Here are some of the allegations made in recently filed Ozempic blindness legal cases:

• Despite available information, the drug company Novo Nordisk failed to warn patients about the risk of developing nonarteritic anterior ischemic optic neuropathy (NAION) when using Ozempic.
• Novo Nordisk knew or should have known that there was reasonable evidence of a causal association between the use of Ozempic and NAION based on preclinical trials, premarket clinical trials, post-market surveillance, and adverse event reports about NAION being associated with Ozempic or other semaglutide drugs, such as Wegovy and Rybelsus.
• A patient who suffered blindness due to NAION would not have used Ozempic — whether for type 2 diabetes treatment or as a weight-loss medication — if they had been provided a warning by Novo Nordisk about the risk of developing NAION when using Ozempic.

We have been investigating Ozempic blindness legal cases for almost a year now, starting soon after we published this article, “Wegovy, Rybelsus, and Ozempic Eye Side Effects: Semaglutide Linked to NAION“, on our Drug Injury Watch website back in early July 2024.

As indicated above, patients who have been diagnosed with semaglutide-related NAION and experienced blindness or vision loss may be entitled to legal compensation by filing a drug injury lawsuit against Novo Nordisk, the pharmaceutical company responsible for Ozempic, Wegovy, and Rybelsus.

Let us know if we can assist you or someone you know with an Ozempic blindness legal case involving NAION. Call (910) 256-2971 to speak directly to attorney Tom Lamb about a possible Ozempic drug injury lawsuit.

Given an apparent delay in the onset of vision loss linked to Ozempic and Rybelsus leading to a NAION diagnosis, it seems we may have a still-emerging drug injury lawsuit situation here. That is, the increasing use of Ozempic and Rybelsus in combination with this delay in vision loss leading to a NAION diagnosis means we might be just at the start of hearing from diabetes patients who have suffered this blinding eye-related side effect.

Drug injury lawsuits involving vision loss linked to Ozempic or Rybelsus filed for patients with a diagnosis of NAION (nonarteritic anterior ischemic optic neuropathy) would be against Novo Nordisk for its failure to warn about such vision loss. This is because the current drug labels for Ozempic and Rybelsus do not warn about any eye-related side effects, such as vision loss and blindness due to NAION.

We have been investigating possible drug injury lawsuits for patients who developed vision loss linked to Ozempic and Rybelsus, two of three semaglutide-containing drugs from Novo Nordisk. Their other semaglutide drug is Wegovy, approved by the FDA as a treatment for adult obesity and used for weight loss.

Let us know if we can assist you or someone else with an Ozempic, Rybelsus, or Wegovy drug injury case concerning nonarteritic anterior ischemic optic neuropathy (NAION) leading to vision loss.

There are a couple of recent medical studies about semaglutide being associated with an increased risk of NAION that provide us with more information about Rybelsus, Wegovy, and Ozempic eye problems.

The first study was reported in the medical journal International Journal of Retina and Vitreous. It found that semaglutide was associated with a higher risk of NAION, having a 2.19 hazard ratio.

The second study, which is in preprint form and not yet published in a peer-reviewed journal (but was posted December 11, 2024, online at medRxiv) “…confirms that use of semaglutide is associated to an increased risk of NAION but also that the excess absolute risk is low.”

The Brigham and Women’s Hospital website provides some basic medical information about non-arteritic anterior ischemic optic neuropathy (NAION). People diagnosed with NAION often experience some degree of permanent vision impairment, which can be life-altering.

Our first article concerning Ozempic eye problems, “Ozempic Side Effects Include Eye Problems With Possible Vision Loss“, was posted in July 2024. Our second article was posted several months later, “Ozempic Linked to Vision Loss With Increased Risk of NAION Side Effect“.

We are investigating drug injury lawsuits seeking legal compensation for people who received a diagnosis of NAION (non-arteritic anterior ischemic optic neuropathy) while using one of Novo Nordisk’s semaglutide drugs, Ozempic, Wegovy, or Rybelsus.

The PRAC has recommended measures to minimise the risk of meningioma, a type of brain tumour, with medicines containing medroxyprogesterone acetate [such as Depo-Provera]….

The PRAC has agreed a direct healthcare professional communication (DHPC) to inform healthcare professionals of the increased risk of developing meningioma with high doses of medroxyprogesterone acetate (all injectable and ≥100 mg oral formulations), primarily after prolonged use (several years). The DHPC will highlight that medicines containing high doses of medroxyprogesterone acetate, when used for contraception or non-oncological indications, are contraindicated in patients with meningioma or with a history of meningioma. If a meningioma is diagnosed in a patient treated with high doses medroxyprogesterone acetate, treatment must be stopped.

An important issue in the increasing number of Depo-Provera meningioma drug injury lawsuits will be why the drug companies responsible for Depo-Provera used by women in the US did not, and still do not, include any Depo-Provera warning about meningioma in their drug label.

We will watch for developments regarding this Depo-Provera drug safety and legal issue.

Essentially, these Depo-Provera drug injury lawsuits are based on the general contention that the pharmaceutical companies knew that Depo-Provera was unreasonably unsafe and unfit for use due to the “product defect” of an increased risk of intracranial meningioma associated with Depo-Provera. And to make things worse, those companies have failed to warn about meningioma to women and their doctors here in the US.

Here are some of the relevant allegations found in the Complaints filed for these Depo-Provera drug injury lawsuits:

• To date, the US Depo-Provera drug label does not mention the increased risk to patients of developing intracranial meningiomas, even though the European Union (EU) and the United Kingdom (UK) drug labels list meningioma under the “special warnings and precautions for use” section and advise patients to speak with their doctors before using Depo-Provera if they have a history of meningioma.
• Moreover, the Canadian drug label for Depo-Provera has listed “meningioma” among its “Post-Market Adverse Drug Reactions” since at least 2015.
• Several scientific studies — dating back to the 1980s and during the decades since — have established that progesterone, its synthetic analog progestin, and Depo-Provera in particular, cause or substantially contribute to the development of intracranial meningioma, a type of brain tumor.

We are investigating Depo-Provera drug injury lawsuits for women who have been diagnosed with intracranial meningioma and want legal compensation from the responsible pharmaceutical companies.

At this time, it is unclear whether there will be an AstraZeneca drug recall of Andexxa. Some possibilities are that the FDA will seek withdrawal of this AstraZeneca anticoagulant reversal drug or request additional confirmatory data for Andexxa, as seen below.

From a December 17, 2024, FirstWord PHARMA news report, “Fate of AstraZeneca’s Andexxa unclear as FDA rejects full approval”:

Less than a month after a bruising FDA advisory committee meeting, the agency has issued a complete response letter (CRL) regarding AstraZeneca’s bid to convert its anticoagulant reversal drug Andexxa (andexanet alfa) from accelerated to full approval.

The fate of Andexxa is unclear at this stage; the FDA could seek withdrawal of the drug or ask for additional confirmatory data. AstraZeneca told FirstWord that “while discussions with the FDA are ongoing, Andexxa will remain on the US market.”

And from a December 13, 2024, Pink Sheet news report, “AstraZeneca Says Andexxa Will Not Convert To Full Approval, Quietly Reveals Complete Response”:

The next steps for the drug following the [FDA-issued complete response letter [(CRL)], which has not been publicly announced by the company, are unclear. Neither AstraZeneca nor FDA would provide much additional information about the product’s standing….

The agency could move to withdraw the drug from the market or ask the company to conduct additional studies to verify a favorable risk-benefit balance.

AstraZeneca told the Pink Sheet that the drug will remain on the US market while discussions with the agency about next steps continue. But the company would not comment on whether those discussions include potential new trials.

We are interested in hearing from patients who developed a pulmonary embolism (PE) or deep vein thrombosis (DVT) to investigate those situations as possible Andexxa blood clot cases that would be filed as drug injury lawsuits against AstraZeneca.

This comes from the December 18, 2024, Reuters news report, “Novo Nordisk’s Ozempic faces EU review for potential eye disease connection”.

How this new investigation of Ozempic linked to vision loss by the European Committee for the Evaluation of Adverse Reactions, or PRAC, came about is explained by this December 16, 2024, Bloomberg article, “Ozempic Blinding Link in Study Prompts Agency to Seek Probe”:

The Danish Medicines Agency said it would ask European authorities to review two new studies that point to a link between Novo Nordisk A/S’s blockbuster shot Ozempic and a rare form of vision loss…

A pair of large studies from the University of Southern Denmark “strengthen the suspicion” of a link between Ozempic and the rare eye condition, called NAION, the agency said.

Conducted independently, the studies both found that people who took Ozempic faced more than twice the risk of the eye condition, which can cause blindness. Both appear to confirm a link first suggested earlier this year in a Harvard University study…. [emphasis added]

Besides Ozempic, this vision loss side effect is possible with Wegovy and Rybelsus because, like Ozmpic, the active ingredient for these other two Novo Nordisk drugs is semaglutide. It is semaglutide specifically that has been associated with nonarteritic anterior ischemic optic neuropathy (NAION) in several medical studies to date.

People who have been diagnosed with NAION after their use of the use of Ozempic, Wegovy, or Rybelsus and experienced vision loss may be entitled to legal compensation by filing a drug injury lawsuit against Novo Nordisk.

We point out that NAION is sometimes referred to more simply as an “eye stroke” and, as it is a form of “optic neuropathy” (an eye disease category), NAION may be noted only as optic neuropathy in the medical records.

The current version of the Prescribing Information document for Ocaliva (Revised: 5/2022) has a so-called Black Box Warning for cases of serious liver injury involving patients with diagnosed cirrhosis who used Ocaliva. Specifically, this Black Box Warning text was added to this Ocaliva drug label in May 2021:

WARNING: HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY
BILIARY CHOLANGITIS PATIENTS WITH CIRRHOSIS

• Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in primary biliary cholangitis (PBC) patients with either compensated or decompensated cirrhosis [see Warnings and Precautions (5.1)].
• OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension [see Contraindications (4)].
• Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension; or experience clinically significant hepatic adverse reactions while on treatment [see Dosage and Administration (2.3), Warnings and Precautions (5.1)].

We will watch to see whether this December 2024 Ocaliva FDA drug safety warning about cases of serious liver injury among patients without pre-existing cirrhosis results in another Ocaliva label change involving the Black Box Warning or other parts of the Prescribing Information document during the first part of 2025.

For some contextual information, we turn to this November 19, 2024 Endpoints News report “Ahead of adcomm, FDA raises safety questions for AstraZeneca’s reversal agent for life-threatening bleeds”, by Zachary Brennan, Senior Editor:

[Andexxa (andexanet)], a recombinant modified human factor Xa protein, is for patients treated with [Xarelto (rivaroxaban)] or [Eliquis (apixaban)] when rapid reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding. That could include, for example, when a patient needed urgent surgery because of a medical emergency or accident.

Last year, AstraZeneca began plans to shift Andexxa to a full approval from its accelerated approval after halting its confirmatory trial early due to these efficacy findings.

But FDA explained how the confirmatory trial, known as ANNEXA-I, revealed “major safety findings” including a “doubling of the rate of thromboses and thrombosis related deaths at Day 30 in the [Andexxa (andexanet)] arm compared with” a standard of care clotting agent known as a prothrombin complex concentrate.

Of the 239 patients treated with [Andexxa (andexanet)], FDA said, 14.6% of patients suffered thrombotic events versus 6.9% in the standard of care arm.

There has been speculation that this increased risk of Andexxa blood clots and clotting-related deaths might lead to an eventual drug recall. For example, the headline for an article published November 20, 2024, by Pink Sheet is “AstraZeneca’s Andexxa Could Be Headed For Withdrawal After US FDA’s Negative Advisory Committee Preview”.

We will continue to monitor this emerging drug safety issue of Andexxa blood clots and clotting-related deaths.