Side Effects Blog

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.

Intracranial meningiomas are mostly non-cancerous or non-malignant tumors. However, cancerous or malignant meningiomas account for 40% of cancers in the central nervous system. Both of these forms of intracranial meningioma are potentially serious medical conditions. Meningiomas grow in layers of tissue covering the brain and spinal cord.

If you are interested in reviewing some general medical information about meningioma, we direct you to the Mayo Clinic’s “Symptoms & causes” and “Diagnosis & treatment” web pages.

This March 2024 BMJ article, “Use of progestogens and the risk of intracranial meningioma: national case-control study”, provides these details about the increased risk of those brain tumors from birth control Depo-Provera injections.

Because the current drug label for Depo-Provera Contraceptive Injection (version “Revised: 7/2024”, accessed 10/16/24) does not include any warning about an increased risk of intracranial meningioma, we are investigating possible drug injury lawsuits seeking legal compensation for women who have been diagnosed with those brain tumors.

That type of lawsuit would be a product liability case filed against the responsible pharmaceutical companies for their failure to warn about brain tumors from birth control Depo-Provera injections. We note that the lawsuit would not be against the woman’s doctors.

Please feel free to contact us to learn more about how the contraceptive injection Depo-Provera being linked to intracranial meningioma might be a drug injury lawsuit seeking legal compensation for women diagnosed with a brain tumor after using this birth control product for years in the past.

A September 20, 2024, Reuters news report, “Court revives more than 500 lawsuits over Fosamax femur fracture risk”, provides a history of prior rulings on the legal defense of federal preemption for the Fosamax MDL femur fracture lawsuits:

The federal litigation stretches back to 2008, and has now been dismissed and revived twice. All of those decisions have hinged on the issue of federal preemption – whether the federal law governing what pharmaceutical companies are required to put on drug labels overrides, or preempts, state law claims that the label fails to warn consumers.

Merck has argued that it does, saying that in 2009 it proposed adding a warning about femur fractures but was initially rejected by the FDA. The warning was eventually added in 2011.

Now-deceased U.S. District Judge Joel Pisano in Trenton, New Jersey, ruled in Merck’s favor on the preemption issue in 2013, but the 3rd Circuit overturned that ruling in 2017, concluding that issue should have been decided by a jury.

The U.S. Supreme Court in 2019 ordered the issue reconsidered once again, saying it was a legal issue for a judge, not a jury.

In 2022, U.S. District Judge Freda Wolfson, who had taken over the case, again sided with Merck on preemption.

The 3rd Circuit on [September 20, 2024], however, again reversed. It said that, even though the FDA had not approved the specific warning proposed by Merck in 2009, it would not necessarily have rejected any warning about femur fractures….

Wolfson has since retired, and the case is now assigned in the trial court to U.S. District Judge Karen Williams. The litigation will return to that court for potential future trials.

We will continue to monitor legal developments for the Fosamax MDL femur fracture lawsuits.