Drug Injury Watch

No Warnings About Blood Clots From Ozempic, Wegovy, and Rybelsus in Drug Labels

Growing Number of Pulmonary Embolism and DVT Cases Involving Semaglutide Reported by Patients

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Wegovy, Rybelsus, and Ozempic have been associated with an increased risk of blood clots that can lead to pulmonary embolism (sometimes called PE) and deep vein thrombosis (often called DVT). However, there are no warnings about blood clots from Ozempic, Wegovy, and Rybelsus in their current Prescribing Information document, commonly called the drug label.

Wegovy, Rybelsus, and Ozempic are drugs with semaglutide as their active ingredient. As we first reported in this February 2024 article, "'New' Blood Clots Side Effect of Semaglutide Weight Loss Drugs Like Ozempic: Deep Vein Thrombosis", it is the semaglutide that has been linked to blood clots:

Somewhat hidden in a relatively recent medical journal article is the mention of a blood clots side effect of semaglutide weight-loss drugs like Ozempic, deep vein thrombosis (DVT). Remarkably, medical researchers found that semaglutide increased the risk of deep vein thrombosis by 266% when doing a study to assess the risk of semaglutide in leading to various serious adverse events (SAEs) in patients with type 2 diabetes.

DVT and Pulmonary Embolism Involving Semaglutide Drugs

Here are some representative case reports of DVT and pulmonary embolism involving semaglutide drugs:

Ozempic - Deep vein thrombosis (DVT) and pulmonary embolism were diagnosed in a 66-year-old woman who had been using Ozempic for 2 months.

Ozempic - Pulmonary embolism (PE) and DVT were diagnosed in a 53-year-old man who had been using Ozempic for 1 year.

Ozempic - Blood clots in both lungs, which is a bilateral pulmonary embolism, were diagnosed in a 46-year-old woman who had been using Ozempic for 2 months.

Rybelsus - DVT was diagnosed in a 62-year-old woman who had been using Rybelsus for 1 month.

 

Other Blood Clot-Related Conditions Involving Semaglutide Drugs

Here are some representative case reports of other blood clot conditions involving semaglutide drugs:

Ozempic - Blood clot in the portal vein, or portal vein thrombosis (PVT), was diagnosed in a 44-year-old woman who had been using Ozempic for 2 weeks.

Wegovy - Ischemic stroke was diagnosed in a 45-year-old man who had been using Wegovy for 3 months.

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No Blood Clot Warnings for Ozempic, Wegovy, and Rybelsus

The current Prescribing Information documents, or drug labels, for Ozempic, Wegovy, and Rybelsus (accessed 7/18/24) do not include any blood clot warnings. As seen below, in the warnings section of those drug labels there is nothing about deep vein thrombosis (DVT), pulmonary embolism (PE), portal vein thrombosis (PVT), ischemic stroke, or any other blood clot-related side effects.

• Ozempic (Revised: 9/2023) [PDF]: 5 WARNINGS AND PRECAUTIONS  5.1 Risk of Thyroid C-Cel Tumors  5.2 Pancreatitis  5.3 Diabetic Retinopathy Complications  5.4 Never Share an OZEMPIC Pen Between Patients  5.5 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin  5.6 Acute Kidney Injury  5.7 Hypersensitivity  5.8 Acute Galbladder Disease
• Wegovy (Revised: 3/2024) [PDF]: 5 WARNINGS AND PRECAUTIONS  5.1 Risk of Thyroid C-Cel Tumors  5.2 Acute Pancreatitis  5.3 Acute Galbladder Disease  5.4 Hypoglycemia  5.5 Acute Kidney Injury  5.6 Hypersensitivity Reactions  5.7 Diabetic Retinopathy Complications in Patients with Type 2 Diabetes  5.8 Heart Rate Increase  5.9 Suicidal Behavior and Ideation
• Rybelsus (Revised: 1/2024) [PDF]: 5 WARNINGS AND PRECAUTIONS  5.1 Risk of Thyroid C-Cel Tumors  5.2 Pancreatitis  5.3 Diabetic Retinopathy Complications  5.4 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin  5.5 Acute Kidney Injury  5.6 Hypersensitivity  5.7 Acute Galbladder Disease

 

We have been investigating possible Ozempic, Rybelsus, and Wegovy drug injury lawsuits for people diagnosed with deep vein thrombosis (DVT), pulmonary embolism (PE), portal vein thrombosis (PVT), ischemic stroke, or any other blood clot-related side effects.

Let us know if we can assist you or someone you know. One way to do this is to submit an online Case Evaluation Form.

Of course, we will continue to watch for developments concerning this relatively new drug safety issue of Wegovy, Rybelsus, and Ozempic being linked to blood clots.

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Wegovy, Rybelsus, and Ozempic Eye Side Effects: Semaglutide Linked to NAION

Nonarteritic Anterior Ischemic Optic Neuropathy (NAION), or "Eye Stroke", Can Cause Vision Loss

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Wegovy, Rybelsus, and Ozempic eye side effects are possible given the recent findings that the active ingredient of these three drugs semaglutide is associated with nonarteritic anterior ischemic optic neuropathy (NAION).

As background, NAION develops from insufficient blood flow to the optic nerve and causes sudden painless vision loss in one eye. It is the second most common cause of blindness due to optic nerve damage, after glaucoma.

We begin our reporting on the new semaglutide side effects findings with this July 3, 2024, STAT news article, "Study links Ozempic to higher risk of eye condition that can cause vision loss":

A new observational study on [July 3, 2024] reported for the first time a potential link between Novo Nordisk’s GLP-1 drugs Ozempic and Wegovy and an eye condition that can cause vision loss.

After hearing anecdotes of patients on the diabetes and obesity drugs experiencing nonarteritic anterior ischemic optic neuropathy, or NAION, researchers at Massachusetts Eye and Ear analyzed data from a registry of patients at their institution to see if there was a broad trend....

In both the diabetes and obesity cohorts that got semaglutide, the researchers found that NAION cases occurred most frequently in the first year after the medications were prescribed.

NAION, sometimes referred to as an “eye stroke,” occurs from a lack of sufficient blood flow to the optic nerve. It typically causes sudden vision loss and, in severe cases, can lead to blindness. There are currently no proven treatments for the condition.

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The medical journal article that presented the new semaglutide eye side effects findings, "Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide", was published on July 3, 2024, by JAMA Ophthalmology, and begins with this Key Points section:

• Question  Are prescriptions for semaglutide associated with an increased risk of nonarteritic anterior ischemic optic neuropathy (NAION) in patients with type 2 diabetes or patients who are overweight or obese?
• Findings  This matched cohort study of 16 827 patients revealed higher risk of NAION in patients prescribed semaglutide compared with patients prescribed non–glucagon-like peptide receptor agonist medications for diabetes or obesity.
• Meaning  The findings suggest a potential risk of NAION associated with prescriptions for semaglutide, but future study is required to assess causality.

A good summary of these Wegovy, Rybelsus, and Ozempic (semaglutide) eye side effects findings was provided in this July 3, 2024, MedPage Today article, "Semaglutide May Be Linked to Condition That Causes Blindness":

Over a mean follow-up of nearly 3 years, patients with diabetes on semaglutide had more than a fourfold higher risk for developing nonarteritic anterior ischemic optic neuropathy (NAION) compared with patients not on a GLP-1 agonist (HR 4.28, 95% CI 1.62-11.29, P<0.001), reported Joseph Rizzo III, MD, of Massachusetts Eye and Ear and Harvard Medical School in Boston, and colleagues.

Those prescribed semaglutide for overweight or obesity had an over sevenfold higher risk for NAION (HR 7.64, 95% CI 2.21-26.36, P<0.001), a significant cause of blindness, they wrote in JAMA Ophthalmology.

Over 3 years, the cumulative incidence of NAION were 8.9% and 6.7% in the two semaglutide groups, respectively, versus 1.8% and 0.8% for the non-GLP-1 groups.

"Despite evidence of neuroprotective properties, expression of the GLP-1 receptor in the human optic nerve and GLP-1 [receptor agonist] RA-induced enhanced sympathetic nervous system activity might influence optic nerve head perfusion and potentially increase the risk of NAION," suggested Rizzo and co-authors.

We are interested in hearing from patients who developed NAION following the use of Ozempic, Wegovy, or Rybelsus. 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.

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.

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