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Law Offices of Thomas J. Lamb

A Rybelsus Blood Clots DVT Case

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We have been investigating Ozempic, Wegovy, and Rybelsus blood clots, deep vein thrombosis (DVT), and pulmonary embolism (PE) cases as possible drug injury lawsuits against the pharmaceutical company Novo Nordisk. Starting in or about 2021, Ozempic, Wegovy, and Rybelsus — the three Novo Nordisk semaglutide-containing drugs — have been associated with a significantly increased risk of blood clots. In this post, we point out a recent medical journal article that discusses a Rybelsus blood clots DVT case involving a teenage boy.

From the Abstract part of this medical journal article, “Deep Venous Thrombosis Within Two Weeks of Initiating Oral Semaglutide (Rybelsus): A Case Report”, we get some information about the Rybelsus blood clots DVT case:

We report the case of a 16-year-old male with mild conventional risk factors for thrombosis [overweight body mass index (BMI) and prolonged sedentary behavior] who developed acute left lower extremity deep venous thrombosis (DVT) within two weeks of initiating [Rybelsus (oral semaglutide)] for weight reduction without medical supervision. He presented with progressive leg pain and swelling, and duplex ultrasonography revealed thrombosis of the distal superficial femoral and popliteal veins….

This case suggests a possible association between [Rybelsus (oral semaglutide)] and venous thrombosis in an adolescent, highlighting the need for careful supervision during off-label use.

We have written previously about the Ozempic, Wegovy, and Rybelsus blood clots side effects of deep vein thrombosis (DVT) and pulmonary embolism (PE):

Semaglutide-Related Blood Clots Cases: Ozempic, Wegovy, and Rybelsus

Deep Vein Thrombosis When Using Wegovy, Rybelsus, or Ozempic

Wegovy / Rybelsus / Ozempic Deep Vein Thrombosis Side Effects

We can assist individuals with a Rybelsus blood clots DVT case if they submit an online Case Evaluation Form or call us at 910-256-2971.

[Read the article in full at Drug Injury Watch]

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Andexxa Blood Clot Drug Injury Lawsuits

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We are investigating possible Andexxa blood clot drug injury lawsuits for patients who developed a pulmonary embolism (PE) or deep vein thrombosis (DVT), or the families of those who died while using Andexxa.

As background, here are our earlier posts:

According to this December 12, 2025, MedPage Today news report, “Anticoagulant Reversal Drug Pulled From U.S. Market“, we learned that Andexxa will be withdrawn from the US market next week, on December 22, 2025.

The pharmaceutical company responsible for Andexxa, AstraZeneca, asserts that this Andexxa recall has to do with “commercial reasons”. However, that December 2025 MedPage Today article, as we had previously, points out Andexxa blood clots that have been associated with Andexxa use:

Safety concerns arose as early as 2016’s ANNEXA-4 initial study presentation, however, when outside observers noted a signal of excess thrombotic events among the study’s [Andessa (andexanet)] users. The clotting issue became more apparent with ANNEXA-I showing more thrombotic events (14.6% vs 6.9%) and more thrombosis-related deaths (2.5% vs 0.9%) comparing [Andessa (andexanet)] versus usual care with a prothrombin complex concentrate (PCC).

Even before this December 2025 Andexxa recall in the US, we had been looking into possible Andexxa blood clot drug injury lawsuits for patients who developed a pulmonary embolism (PE) or deep vein thrombosis (DVT), causing them to be hospitalized or resulting in their death.

For those people, we encourage you to submit an Andexxa Blood Clots Case Evaluation Form online – it is free, confidential, and there is no obligation.

[Read the article in full at Drug Injury Watch]

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NAION With Tirzepatide-containing Drugs Mounjaro and Zepbound

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The possible connection of NAION with tirzepatide-containing drugs Mounjaro and Zepbound is being investigated by the FDA, according to “October – December 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)”.

During the past year, we have written about the vision loss side effect NAION (non-arteritic anterior ischemic optic neuropathy) being linked to semaglutide-containing drugs Ozempic, Rybelsus, and Wegovy. This is our first article about the possible connection of NAION with tirzepatide-containing drugs Mounjaro and Zepbound.

We will watch for developments concerning the possible connection of NAION with tirzepatide-containing drugs Mounjaro and Zepbound.

If you have developed NAION with Mounjaro or Zepbound, there might be a drug injury lawsuit against the responsible pharmaceutical company. Please don’t hesitate to contact us if you are interested in such a case.

[Read the article in full at source]

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Link Between Ozempic and NAION Also Involves the Eye Disorder AION

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The European Medicines Agency (EMA) confirmed the link between Ozempic and NAION (non-arteritic anterior ischemic optic neuropathy) in early June 2025. This drug regulator went on to say a NAION warning would be added to the drug labels for the semaglutide-containing drugs Wegovy, Rybelsus, and Ozempic. Notably, but not surprisingly, the EMA did not mention the lesser-known eye disorder AION (anterior ischemic optic neuropathy) concerning the semaglutide drug label changes.

An excerpt from a Survey of Ophthalmology medical journal article explains the relationship between NAION and AION:

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.

[Read the article in full at source]

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Vision Loss Linked to Ozempic and Rybelsus Use by Diabetes Patients

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The relatively new drug safety issue of vision loss linked to Ozempic and Rybelsus was the subject of a recent medical study that had this stated Objective, or purpose: “To investigate the association between semaglutide use and the risk of NAION among patients with diabetes.”

On March 27, 2025, the JAMA Ophthalmology medical journal published this report, “Semaglutide and Nonarteritic Anterior Ischemic Optic Neuropathy Risk Among Patients With Diabetes”, about that recent medical study. Of particular significance is that it presents new information about the time relationship between Ozempic and Rybelsus use dates by patients with type 2 diabetes and the diagnosis dates for their NAION. This can be found in the Results section of that March 2025 JAMA Ophthalmology article, at a part titled “Risk of NAION in Terms of Follow-Up Duration After Semaglutide Prescription”.

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.

[Read the article in full at source]

Ozempic / Rybelsus / Wegovy

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Ocaliva FDA Drug Safety Warning December 2024

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An Ocaliva FDA drug safety warning was issued by the FDA in December 2024 that pointed out cases of liver transplants and liver-related deaths among patients without pre-existing cirrhosis who used Ocaliva as a treatment for primary biliary cholangitis (PBC).

To provide context for this most recent Ocaliva FDA drug safety warning, we refer you to this article: “FDA Safety Evaluation Finds Ocaliva-related Liver Injury in Primary Biliary Cholangitis (PBC) Patients with Advanced Cirrhosis — May 2021 FDA Drug Safety Communication: Ocaliva Label Change: Prescribing Information Will be Adding and Updating Warnings”.

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 the 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.

[Read the article in full at source]

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Deep Vein Thrombosis When Using Wegovy, Rybelsus, or Ozempic

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Drug injury lawsuits that might be filed against the pharmaceutical company Novo Nordisk involving a stroke, pulmonary embolism, or deep vein thrombosis when using Wegovy, Rybelsus, or Ozempic are somewhat like the federal court Wegovy/Rybelsus/Ozempic MDL lawsuits involving gastrointestinal and stomach problems because they would involve similar — but different — liability issues, such as:

  • Whether Novo Nordisk knew or should have known that its semaglutide-containing drugs Wegovy, Rybelsus, and Ozempic can cause ischemic strokes (which are strokes caused by blood clots), pulmonary embolism (PE), or deep vein thrombosis (DVT) — as opposed to gastroparesis, gastric stasis, stomach paralysis, and other semaglutide-related stomach conditions;
  • Whether Novo Nordisk adequately warned the patient or their prescribing doctor about the alleged increased risk of blood clots of Wegovy, Rybelsus, Ozempic that can lead to a stroke, PE, or DVT; and,
  • Whether Novo Nordisk made false, misleading, or incomplete representations regarding the drug safety of Wegovy, Rybelsus, and Ozempic.

In more detail, drug injury lawsuits for people using Wegovy, Rybelsus, or Ozempic diagnosed with gastroparesis, gastric stasis, stomach paralysis, and other semaglutide-related stomach conditions are in this federal court MDL: IN RE: GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS (GLP-1 RAS) PRODUCTS LIABILITY LITIGATION, MDL No. 3094.

However, drug injury lawsuits involving a stroke, pulmonary embolism, or deep vein thrombosis when using Wegovy, Rybelsus, or Ozempic would not be part of federal court MDL No. 3094 as currently configured in the February 2024 Transfer Order because that federal court MDL does not include stroke, PE, and DVT cases.

We have been investigating possible drug injury lawsuits against Novo Nordisk involving strokes caused by blood clots as well as PEs and DVTs in patients using Wegovy, Rybelsus, or Ozempic.

If we can assist you or someone you know, our Drug Injury Case Evaluation Form is available online, or you can call us at (800) 426-9535 to discuss a possible Wegovy, Rybelsus, or Ozempic case.

[Read article in full at original source]

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Symptoms and Diagnosis of Weight-Loss Drugs Gastroparesis Side Effects for Ozempic, Rybelsus, Wegovy, and Trulicity

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To start, we point out two medical journal articles that present a few weight-loss drugs gastroparesis side effects reports involving the use of semaglutide (Ozempic, Rybelsus, Wegovy) or dulaglutide (Trulicity):

  1. Tendency of Semaglutide to Induce Gastroparesis: A Case Report
  2. Medication-Induced Gastroparesis: A Case Report

Significantly, these medical journal articles provide some helpful information about symptoms and diagnosis of the weight-loss drugs gastroparesis side effects that have been associated with Ozempic, Rybelsus, Wegovy, and Trulicity.

In the past six months on our Drug Injury Watch blog, we have written several times about the weight-loss drugs gastroparesis side effects:

Ozempic / Wegovy: Stomach And Intestinal Problems Can Be Irreversible, Life-threatening — Severe Gastric Side Effects Include Stomach Paralysis, Gastroparesis, And Intestinal Blockages (9/1/23)

Severe Stomach Conditions in Patients Using Semaglutide Weight Loss Drugs From Novo Nordisk — Ozempic, Rybelsus, and Wegovy Use Might Cause Gastroparesis, Gastric Stasis, or Stomach Paralysis (9/13/23)

Ozempic, Wegovy, Other GLP-1 Semaglutide Weight-Loss Drugs Linked to Gastroparesis in Recent Medical Study — Researchers Compared Semaglutide Drugs, Such as Ozempic and Wegovy, to Contrave, a Non-GLP-1 Drug, in Weight-Loss Patients (10/24/23)

We are handling drug injury lawsuits for people who used Ozempic, Rybelsus, Wegovy, or Trulicity and then were diagnosed with the weight-loss drugs gastroparesis side effects.

[Read article in full at original source]

Ozempic / Rybelsus / Wegovy/ Trulicity

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Prolia Hypocalcemia Side Effect in Patients With Chronic Kidney Disease Warning Added to Prolia Drug Label

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A January 2024 Prolia drug label change that added a “Black-Box” warning for the “new” Prolia hypocalcemia side effect was announced through this Drug Safety Communication “FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab).”

This Prolia drug label change followed the publication of a January 2024 JAMA Original Investigation article, “Severe Hypocalcemia With Denosumab Among Older Female Dialysis-Dependent Patients”.  In summary, it presents evidence of a Prolia increased risk of hypocalcemia in patients with chronic kidney disease (CKD) that can be 20 times higher than bisphosphonate pills.

To make clear the significance of these Prolia hypocalcemia side effect findings, and why the FDA mandated a Prolia “Black-Box” warning, we turn to this January 19, 2024, MedPage Today news report, “Calcium Levels Quickly Become Critical for Many Denosumab-Treated Women on Dialysis”:

Many women on dialysis quickly developed severe hypocalcemia after starting denosumab (Prolia) for osteoporosis, Medicare data showed.

During the first 12 weeks of treatment, 41.1% of women on [Prolia (denosumab)] developed severe hypocalcemia compared with 2.0% of those taking oral bisphosphonates, reported a group of largely FDA researchers led by Steven Bird, PhD, PharmD, of the agency offices in Silver Spring, Maryland.

This translated to more than a 20-times higher risk for incident severe hypocalcemia with [Prolia (denosumab)] (weighted risk ratio 20.7, 95% CI 13.2-41.2), according to the retrospective cohort study in JAMA.

We will continue to monitor this still-developing Prolia drug safety issue involving severe hypocalcemia in Porlia patients with advanced chronic kidney disease (CKD).

Lastly, we have started to investigate possible drug injury lawsuits for patients with advanced chronic kidney disease (CKD) taking Prolia who developed this severe hypocalcemia side effect.

[Read the article in full at source]

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Syfovre Side Effects Issue Raised In December 2023 JAMA Viewpoint Piece

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A December 2023 JAMA Ophthalmology Viewpoint piece about Syfovre side effects was reported on in a December 7, 2023, Managed Healthcare Executive article, “Independent Assessment of Syfovre Needed, Argues JAMA Ophthalmologist Viewpoint”:

An independent panel of retinal specialists and statisticians should assess the clinical trial data for Syfovre (pegcetacoplan injection) and provide an unbiased evaluation of the drug in light of the lack of peer-review publication and a complete FDA review, argues Ira Schachar, M.D., M.Sc., the author of an opinion piece published today in JAMA Ophthalmology.

Schachar also suggests that widespread use of Syfovre should wait until there is a complete FDA scientific analysis of the drug or a peer-reviewed publication of the study results. He says the data released by Apellis Pharmaceuticals raises methodological questions and he questions whether “repeated measures and missing data have been appropriately handled.” Schachar, who was an assistant professor at Stanford prior to joining the North Bay group, says in the one-page viewpoint piece that questions about the Syfovre statistics are “particularly important” because of the high dropout rates from two important, phase 3 trials for the drug called OAKS and DERBY.

This Viewpoint piece about Syfovre side effects, “Concerning Syfovre Approval for Geographic Atrophy”, was published December 7, 2023, online by JAMA Ophthalmology.

The results of the clinical trials OAKS and DERBY were reported in this medical journal article, “Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials”, published October 21, 2023, by The Lancet.

In the Interpretation part of the Abstract for this Lancet medical journal article, lead author Jeffrey S. Heier, M.D., of Ophthalmic Consultant of Boston, and his colleagues stated:

[Syfovre (pegcetacoplan)], the first treatment approved by the US Food and Drug Administration for geographic atrophy, slowed geographic atrophy lesion growth with an acceptable safety profile.

The OAKS and DERBY trials were funded by Apellis Pharmaceuticals. Whether those two phase 3 trials adequately addressed Syfovre side effects seems to be the issue raised by Dr. Schachar in his December 2023 Viewpoint piece.

[Read article in full at original source]

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Law Offices of Thomas J. Lamb, P.A.
1908 Eastwood Road, Suite 225
Wilmington, North Carolina 28403
910-256-2971
TJL@LambLawOffice.com