Drug Injury Watch

"New" Blood Clots Side Effect of Semaglutide Weight Loss Drugs Like Ozempic: Deep Vein Thrombosis

Research Finding: Semaglutide Increased the Risk of Deep Vein Thrombosis (DVT) by 266% in Patients with Type 2 Diabetes

 

(Posted by Tom Lamb at Drug Injury Watch)

 

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UPDATE

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

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

(7/19/24)

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Semaglutide-containing drugs that are being used for weight loss purposes include Ozempic, Rybelsus, and Wegovy. 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.

This semaglutide deep vein thrombosis side effect finding is particularly alarming since patients who have type 2 diabetes and who are obese are already at an increased risk of deep vein thrombosis (DVT). Not surprisingly, then, the authors of this medical journal article concluded their semaglutide deep vein thrombosis side effect finding indicates semaglutide weight-loss drugs like Ozempic perhaps should be avoided by obese people with type 2 diabetes.

The medical journal article that included this discussion of semaglutide DVT side effects is "Comprehensive analysis of the safety of semaglutide in type 2 diabetes: a meta-analysis of the SUSTAIN and PIONEER trials", published by the Endocrine Journal back in 2021 (Volume 68, Issue 6, Pages 739-742). For an overview, we start with the Abstract:

The PIONEER and SUSTAIN serial trials are designed to assess the efficacy outcomes with semaglutide in patients with type 2 diabetes, but are not powered to assess various safety outcomes. We sought to assess the risk of semaglutide in leading to various serious adverse events (SAEs) in patients with type 2 diabetes. Studies eligible for inclusion were the PIONEER and SUSTAIN trials of semaglutide. We conducted meta-analysis to generate pooled risk ratios (RRs) and 95% confidence intervals (CIs). Meta-analysis was performed using both random-effects and fixed-effects model to evaluate the robustness of pooled results. We implemented subgroup analysis according to drug dosages and routes of administration and type of comparators. Twenty-one trials were included. Semaglutide versus control significantly reduced total SAEs (RR 0.92, 95% CI 0.87–0.97; I2 = 0) and atrial fibrillation (RR 0.69, 95% CI 0.50–0.95; I2 = 0), but significantly increased deep vein thrombosis (RR 3.66, 95% CI 1.09–12.25; I2 = 0) and diarrhoea (RR 2.66, 95% CI 1.19–5.95; I2 = 0). Semaglutide had no significant effects on 248 other kinds of SAEs. No statistically significant subgroup effects were observed. Semaglutide has a good safety profile in general and reduces atrial fibrillation by 31%, but increases diarrhoea by 166% and deep vein thrombosis by 266%. These findings may guide that semaglutide should be preferred or avoided in T2D patients with specific susceptibility factors.  [Emphasis added.]

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In the Discussion section of this 2021 Endocrine Journal article, the authors consider why there is an apparent association between semaglutide weight-loss drugs like Ozempic and deep vein thrombosis (DVT):

Since semaglutide was observed to increase the risk of both diarrhoea and deep vein thrombosis in this meta-analysis, and diarrhoea or dehydration can lead to the increase in blood viscosity, semaglutide increases the risk of deep vein thrombosis possibly due to increasing that of diarrhoea. Moreover, whether an increase in deep vein thrombosis is related to a decrease in body weight also needs to be further investigated....

Here is some medical information about deep vein thrombosis (also known as deep venous thrombosis) from the Mayo Clinic, the U.S. National Institute of Health’s Medline Plus, and the Centers for Disease Control and Prevention.

Previously we have written several articles about an increasing number of adverse event reports that involve severe stomach conditions such as gastroparesis, gastric stasis, and stomach paralysis associated with Ozempic, Wegovy, and Rybelsus, the three popular GLP-1 receptor agonists containing semaglutide used as weight-loss drugs:

• Gastroparesis Case Reports Involving the Use of GLP-1 Receptor Agonists Semaglutide and Dulaglutide (2/9/24)
  
  
• Ozempic, Wegovy, Other GLP-1 Semaglutide Weight-Loss Drugs Linked to Gastroparesis in Recent Medical Study (10/24/23)
  
  
• Ozempic: Reports of Gastrointestinal Disorder Ileus Added to Drug Label in September 2023 (9/28/23)
  
  
• Severe Stomach Conditions in Patients Using Semaglutide Weight Loss Drugs From Novo Nordisk (9/13/23)
  
  
• Ozempic / Wegovy: Stomach And Intestinal Problems Can Be Irreversible, Life-threatening (9/1/23)

We continue to investigate Ozempic, Rybelsus, and Wegovy drug injury lawsuits for people diagnosed with gastroparesis, gastric stasis, or stomach paralysis and hospitalized for one of those possible semaglutide-related stomach conditions.

In addition, we are looking into possible drug injury lawsuits involving deep vein thrombosis (DVT) as a blood clots side effect of semaglutide weight-loss drugs like Ozempic, Rybelsus, and Wegovy.

Let us know if we can assist you or a loved one with a Wegovy, Rybelsus, or Ozempic drug injury case.

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Gastroparesis Case Reports Involving the Use of GLP-1 Receptor Agonists Semaglutide and Dulaglutide

Learn About Related Symptoms and Diagnosis Process for Gastroparesis, a Side Effect of Ozempic, Wegovy, Rybelsus, and Trulicity

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In this article, we present some gastroparesis case reports involving the use of GLP-1 receptor agonists semaglutide (e.g., Ozempic, Wegovy, Rybelsus) or dulaglutide (e.g., Trulicity) that have been published recently by medical journals. These gastroparesis case reports discuss specific patient profiles, related symptoms, and the diagnosis process for gastroparesis, a side effect of Ozempic, Wegovy, Rybelsus, or Trulicity.

We have written previously about gastroparesis associated with Ozempic, Wegovy, and Rybelsus, three popular GLP-1 receptor agonists containing semaglutide.

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)

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

Now we point out three gastroparesis case reports involving the use of semaglutide (e.g., Ozempic, Wegovy, Rybelsus) or dulaglutide (e.g., Trulicity) that we found in two medical journal articles, and present some valuable information from each of these gastroparesis case reports.

(1) Tendency of Semaglutide to Induce Gastroparesis: A Case Report

A 53-year-old woman with a medical history of depression, obesity stage 2, and obstructive sleep apnea presented to the hospital due to nausea and abdominal pain for the last three weeks. She also reported a weekly intramuscular injection of 0.5 mg of semaglutide for the preceding four months for weight loss, with an estimated 40-pound loss during this period. She did not escalate the dose of semaglutide for weight loss as recommended, as she was satisfied with the response to the initial dose....

In this case, the patient's use of semaglutide and her symptoms of gastroparesis seem to be strongly related. By stimulating glucagon-like peptide-1 (GLP-1) receptor agonists, it increases incretin action. Furthermore, better blood glucose levels are achieved by increased glucose-dependent insulin secretion, decreased hepatic gluconeogenesis, delayed gastric emptying, and inhibited glucagon release. Additionally, semaglutide encourages weight loss by delaying gastric emptying and decreasing energy intake. Semaglutide mainly binds to plasma proteins, has a half-life of approximately one week, and remains in circulation for about five weeks after the last dose. Its effects increase in a dose-proportional manner, and a steady state is achieved after four to five weeks of once-weekly administration.

The exact mechanism by which semaglutide may cause gastroparesis is unknown. Nonetheless, it is well recognized that GLP-1 receptors regulate stomach emptying and motility. Therefore, the stimulation of these receptors may cause gastroparesis by delaying the stomach's emptying....

Proof of delayed gastric emptying in gastric emptying studies is required for the diagnosis, in addition to the absence of mechanical blockage. Consequently, upper and occasionally lower endoscopies are frequently included in the workup. The decision to forgo a gastric emptying study for our patient was made due to financial concerns and clinical evidence observed during repeated endoscopy, which included the presence of food material in the stomach 24 hours apart and the absence of mechanical blockage. A gastric emptying study is considered positive for gastroparesis if there is more than 60% of retaining food after 2 hours or 10% after 4 hours.  [Footnotes omitted]

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(2) Medication-Induced Gastroparesis: A Case Report

The first case is that of a 52-year-old female with a long-standing history (10 years) of type 2 DM who was referred to our clinic for a 7-month history of postprandial epigastric pain, accompanied by fullness, bloating, and nausea. Multiple pharmacologics were tried to relieve the symptoms such as proton pump inhibitors and antispasmodics (anticholinergics), however with no relief. Laboratory tests and computed tomography of the abdomen were unremarkable. Patient had an HbA1c of 5.7% (well-controlled diabetes). Prior upper and lower endoscopies showed no evidence of obstruction, and biopsy was negative for Heliobacter pylori. A hepatobiliary iminodiacetic acid (HIDA) scan was also done in the past which ruled out gallbladder dyskinesia, and an abdominal Doppler blood flow study ruled out median arcuate ligament syndrome. Upon extensive history taking, it was found that the patient had started semaglutide (a glucagon-like peptide-1 [GLP-1] receptor agonist) subcutaneous injection weekly, approximately 1 month prior to the onset of symptoms. A 4-hour scintigraphic gastric emptying study (GES) showed 24% retention of isotope in the stomach at 4 hours which indicates delayed gastric emptying (GE) as gastric residual remaining at 4 hours should be <10%. Semaglutide was subsequently held for 6 weeks with resolution of symptoms. A repeat GES was then performed and showed resolution of delayed GE (Table 1).

The second case is that of a 57-year-old female with a long-standing history (16 years) of type 2 DM presenting with abdominal bloating, nausea, and vomiting for the past year. Labs were significant for a HbA1C of 8.2%. Previous upper endoscopy and colonoscopy did not reveal any obstruction or other abnormalities; however, she never received a GES. In addition, patient started dulaglutide subcutaneous weekly injection (GLP-1 receptor agonist) approximately 15 months ago. A 4-hour scintigraphic GES showed 35% retention of isotope in the stomach at 4 hours, revealing delayed GE. Subsequently, dulaglutide was discontinued for 4 weeks with gradual resolution of symptoms. A repeat GES was then performed and showed normalization of GE (Table 2).

We continue to investigate drug injury lawsuits for people who used Ozempic, Rybelsus, Wegovy, or Trulicity and then were diagnosed with serious gastrointestinal side effects like gastroparesis, gastric stasis, or stomach paralysis.

If we can assist you or someone you know, you can contact me by email ([email protected]) or phone (800-426-9535).

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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

 

(Posted by Tom Lamb at Drug Injury Watch)

 

An October 2023 medical journal article presented the results of a recent study comparing patients who used two different types of weight-loss drugs to see whether drugs containing the GLP-1 semaglutide showed Ozempic and Wegovy associated with gastroparesis, a gastrointestinal condition also referred to as stomach paralysis.

Even those two Novo Nordisk drugs, Ozempic and Wegovy, each have semaglutide as their active ingredient, they were approved by the FDA for different purposes. Ozempic is intended for patients with diabetes and Wegovy was approved for those with obesity. However, over the past couple of years, Ozempic has been increasingly used "off-label" as a weight-loss drug, too.

For this recent medical study, semaglutide drugs such as Ozempic and Wegovy were compared to Contrave, a non-GLP-1 weight-loss treatment.  It is important to point out that for this study none of the patients had diabetes and all of the patients were prescribed the two different types of drugs for weight loss. The reason this fact is significant: "Diabetes is the most common known underlying cause of gastroparesis." See "Symptoms & Causes of Gastroparesis", from the National Institute of Diabetes and Digestive and Kidney Diseases (accessed 10/24/23).

So as regards possible Ozempic-gastroparesis drug injury lawsuits against Novo Nordisk for failure to warn about this serious side effect, the better cases will involve non-diabetic patients using Ozempic "off-label" as a weight-loss treatment.

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With that established, we now direct you to the medical journal article we referred to at the outset of this piece. On October 5, 2023, the Journal of the American Medical Association (JAMA) published online this Research Letter, "Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss", which begins with this introduction to the medical study:

Glucagon-like peptide 1 (GLP-1) agonists are medications approved for treatment of diabetes that recently have also been used off label for weight loss. Studies have found increased risks of gastrointestinal adverse events (biliary disease, pancreatitis, bowel obstruction, and gastroparesis) in patients with diabetes. Because such patients have higher baseline risk for gastrointestinal adverse events, risk in patients taking these drugs for other indications may differ. Randomized trials examining efficacy of GLP-1 agonists for weight loss were not designed to capture these events due to small sample sizes and short follow-up. We examined gastrointestinal adverse events associated with GLP-1 agonists used for weight loss in a clinical setting. [footnotes omitted]

As mentioned above, this recent medical study found that the use of GLP-1 agonists containing the active ingredient semaglutide, such as Ozempic and Wegovy -- when compared with Contrave, a non-GLP-1 drug with the active ingredients naltrexone and bupropion -- was associated with increased risk of gastroparesis.

We are investigating possible drug injury lawsuits against Novo Nordisk for non-diabetic patients who were diagnosed with gastroparesis while using Ozempic "off-label" as a weight-loss treatment as well as Wegovy as an obesity treatment.

In addition, we are investigating gastroparesis cases involving Rybelsus, approved by the FDA as Type 2 diabetes treatment, when it was being used "off-label" for weight loss by people who do not have diabetes.

If you want to learn more, here are a few of our earlier Drug Injury Watch articles about gastroparesis and other gastrointestinal side effects associated with Ozempic, Wegovy, and Rybelsus:

• Ozempic: Reports of Gastrointestinal Disorder Ileus Added to Drug Label in September 2023 -- Paralytic Ileus, the Slowing of Food Movement Through Digestive System, is Similar to Intestinal Obstruction (9/28/23)
• 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: Stomach And Intestinal Problems Can Be Irreversible, Life-threatening -- Severe Gastric Side Effects Include Stomach Paralysis, Gastroparesis, And Intestinal Blockages (9/1/23)

Feel free to contact us about a possible drug injury case involving Ozempic, Wegovy, and Rybelsus. Any such lawsuit would be filed against Novo Nordisk, the responsible drug company, but not your doctor.

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Ozempic: Reports of Gastrointestinal Disorder Ileus Added to Drug Label in September 2023

Paralytic Ileus, the Slowing of Food Movement Through Digestive System, is Similar to Intestinal Obstruction

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In September 2023 the Ozempic (semaglutide) drug label was updated to inform doctors and patients that adverse reaction reports concerning ileus, a gastrointestinal disorder, have been received for semaglutide during the time since Ozempic was first approved by the FDA in 2017. This September 2023 Ozempic label change can be found in part "6.3 Postmarketing Experience" of the Ozempic Full Prescribing Information document ("Revised: 9/2023" version).

Ileus is a medical condition similar to intestinal obstruction but with some distinctions. Essentially, for ileus the bowel does not work correctly, but there is no structural problem causing it; while for intestinal obstruction there is a partial or complete blockage of the bowel.

From a Mayo Clinic website page titled "Intestinal obstruction":

Intestinal obstruction is a blockage that keeps food or liquid from passing through your small intestine or large intestine (colon)....

Intestinal pseudo-obstruction (paralytic ileus) can cause signs and symptoms of intestinal obstruction, but it doesn't involve a physical blockage. In paralytic ileus, muscle or nerve problems disrupt the normal coordinated muscle contractions of the intestines, slowing or stopping the movement of food and fluid through the digestive system.

Getting back to the September 2023 Ozempic label change adding the ileus adverse reaction reports, this September 28, 2023, FiercePharma article, "Novo Nordisk’s Ozempic gets FDA label update flagging risk of intestinal blockage disorder", provides some contextual information:

While GLP-1 drugs from Novo Nordisk and Eli Lilly are believed to be relatively free of serious side effects, a few problems have emerged as the treatments have gained wider and longer-term use.

One came last week, when the FDA revealed that it has updated the label for Novo’s Ozempic, warning of the potential of intestinal blockage.

The condition, known as ileus, can be life threatening and is already listed as a potential side effect on the labels of Eli Lilly’s diabetes drug Mounjaro and Novo’s weight-loss therapy Wegovy, which is the same formulation as Ozempic, just in a higher dose.

On the FDA’s Adverse Events Reporting System (FAERS) public dashboard, the agency has tracked 33 reports of ileus from GLP-1 users, with two deaths....

The risk of ileus was cited earlier this year by a group of Chinese scientists. They wrote that the use of GLP-1 drugs may cause continuous increases in intestinal length, causing it to “become as inelastic and fibrotic as a loose spring.” The possibility of having an intestinal blockage peaks after a year and a half of use, the researchers said, which is longer than the duration of most of the clinical studies involving GLP-1 therapies.

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And we learn about the number of Ozempic gastrointestinal side effects, including ileus cases, that have been reported to the FDA during the first 6 months of 2023 from this September 28, 2023 article, "FDA Adds New Warning for Ileus to Semaglutide (Ozempic) Label", published September 28, 2023, on the HCPLive® website:

According to the US FDA’s Adverse Events Reporting System (FAERS) public dashboard, there have been 2951 total cases of adverse events associated with use of Ozempic during 2023 as of June 30, 2023. The majority of these cases are gastrointestinal-related events, which account for 1274 of the 2951 total cases.

Within the FAERS public dashboard, there were 6 total cases of ileus reported with use of [Ozempic], with 2 resulting in hospitalization. Of note, the number of cases reported so far in 2023 is more than double the total number of cases reported in 2019.

We will watch for more significant developments concerning gastrointestinal conditions such as ileus associated with Ozempic, Rybelsus, and Wegovy, semaglutide-containing drugs from Novo Nordisk.

In the meanwhile, we continue to investigate drug injury lawsuits for people who used Ozempic, Rybelsus, or Wegovy and then were diagnosed with serious gastrointestinal side effects like gastroparesis, gastric stasis, or stomach paralysis.

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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

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Semaglutide is the active ingredient in three Novo Nordisk drugs that are being used for weight loss purposes:

1. Ozempic, which was approved in 2017 by the FDA as a Type 2 diabetes treatment, such that Ozempic is being used "off-label" for weight loss;
2. Rybelsus, approved in 2019 as Type 2 diabetes treatment, is also being used "off-label" for weight loss; and,
3. Wegovy, which was approved in 2021 by the FDA as a treatment for adult obesity and "indicated" for weight loss (and, therefore, not "off-label").

In recent years we have seen an increasing number of adverse event reports for these Novo Nordisk semaglutide weight loss drugs that involve severe stomach conditions, including:

• Gastroparesis
• Gastric Stasis
• Stomach Paralysis

For a general medical definition of these semaglutide-related stomach conditions, we turn to a National Library Medicine webpage titled "Gastric Stasis":

Gastroparesis (gastric stasis) is derived from Greek words gastro/gaster or stomach, and paresis or partial paralysis. It is a clinical condition resulting from delayed gastric emptying in the absence of mechanical obstruction and is associated with upper gastrointestinal symptoms. Most common symptoms include nausea, vomiting, early satiety, postprandial fullness, upper abdominal pain, bloating, and weight loss. These symptoms can be severely disabling and can adversely impact the quality of life in patients suffering from this disorder.

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Given this explanation and description of these severe stomach conditions that have been linked to Ozempic, Rybelsus, and Wegovy, people experiencing gastroparesis or gastric stasis often go to the emergency department/emergency room (ER) of their local hospital, sometimes several different times, before finally being admitted to the hospital.

While an ER doctor may determine that a person using the semaglutide weight loss drug has developed severe stomach conditions and then orders hospital admission, the actual medical diagnosis of gastroparesis or gastric stasis is usually made by a gastroenterologist, also called a GI doctor.

Going back to the increasing number of adverse event reports for Ozempic, Rybelsus, and Wegovy that involve severe stomach conditions, drug injury lawsuits will likely filed against Novo Nordisk. These lawsuits would be based on the failure of Novo Nordisk to include an adequate warning in the drug labels for these semaglutide weight loss drugs about an increased risk of gastroparesis, gastric stasis, or stomach paralysis.

We are currently investigating Ozempic, Rybelsus, and Wegovy drug injury lawsuits for people diagnosed with gastroparesis, gastric stasis, or stomach paralysis, and hospitalized for one of those possible semaglutide-related stomach conditions.

If we can assist you or someone you know, you can contact me by email ([email protected]) or phone (800-426-9535).

Of course, we will continue to monitor the medical and regulatory realms for significant developments regarding severe stomach conditions involving the Novo Nordisk semaglutide weight loss drugs Ozempic, Rybelsus, and Wegovy.

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Ozempic / Wegovy: Stomach And Intestinal Problems Can Be Irreversible, Life-threatening

Severe Gastric Side Effects Include Stomach Paralysis, Gastroparesis, And Intestinal Blockages

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Ozempic has been approved by the FDA as a treatment for diabetes which is increasingly used "off-label" for weight loss purposes. Wegovy is a higher-dose version of Ozempic that is FDA-approved to treat obesity. Both of these relatively new drugs, from the pharmaceutical company Novo Nordisk, contain the active ingredient semaglutide. In the several years since being on the market, there have been an increasing number of so-called "semaglutide-related" gastroparesis, stomach paralysis, and intestinal blockage cases diagnosed in patients using Ozempic or Wegovy.

Related to this situation, due to a "Potential Signal of a Serious Risk / New Safety Information" about intestinal obstruction in patients using Ozempic and Wegovy -- as well as other drugs in the Glucagon-like peptide 1 (GLP-1) receptor agonists class of drugs -- the FDA is evaluating the need for regulatory action. See "April - June 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)".

We point out that the current drug labels for Ozempic and Wegovy do not warn about gastroparesis, stomach paralysis, and intestinal blockages or obstructions being potential side effects of Ozempic and Wegovy. As a result, patients are likely unaware that they are at risk for developing one of these severe gastric side effects, which can require hospitalization and surgery to treat. Furthermore, gastroparesis is a long-term, chronic condition that can be irreversible even after a patient stops using Ozempic or Wegovy. Gastroparesis may also be called delayed gastric emptying.

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This failure to warn doctors about these potential serious stomach or intestinal side effects associated with Ozempic and Wegovy has resulted in drug injury lawsuits filed against Novo Nordisk on behalf of patients who have been diagnosed with gastroparesis, stomach paralysis, and intestinal blockages.

Of course, we will continue to monitor the medical, regulatory, and legal sectors for more information concerning these severe gastric side effects of Ozempic and Wegovy. And be assured we will report significant developments going forward here on Drug Injury Watch.

If we can be of assistance with a possible drug injury lawsuit involving "semaglutide-related" gastroparesis, stomach paralysis, intestinal blockage, or intestinal blockage diagnosed in a patient using Ozempic or Wegovy, please do not hesitate to contact us.

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Januvia, Onglyza, Other Diabetes Drugs In DPP-4 Inhibitor Class Significantly Increase Risk Of Crohn's Disease (CD)

But Same Medical Study Finds That DPP-4 Inhibitors Do Not Increase Risk Of Inflammatory Bowel Disease (IBD)

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Back in March 2018 we wrote this report, "Januvia, Onglyza, And Certain Other Diabetes Drugs Linked To Inflammatory Bowel Disease (IBD)", which was about a study published by The BMJ medical journal about the use of dipeptidyl peptidase-4 (DPP-4) inhibitors for treatment of type 2 diabetes being associated with increased risk for IBD.

Now, about a year later, the medical journal Annals of Pharmacotherapy has published an article, "Dipeptidyl Peptidase-4 Inhibitors and Inflammatory Bowel Disease Risk: A Meta-analysis", which concludes that DPP-4 inhibitors do not appear to increase the risk of developing IBD -- but goes on to point out that these drugs, such as Januvia and Onglyza, increase the risk of Crohn's disease (CD).

The following diabetes medicines are in the DPP-4 inhibitor class of drugs:

Januvia (sitagliptin)
Janumet (sitagliptin / metformin HCl)
Janumet XR (sitagliptin / metformin HCl)
Tradjenta (linagliptin)
Jentadueto (linagliptin / metformin HCl)
Glyxambi (empagliflozin / linagliptin)
Onglyza (saxagliptin)
Kombiglyze XR (saxagliptin and metformin)
Qtern (dapagliflozin and saxagliptin)
Nesina (alogliptin)
Kazano (alogliptin and metformin)
Oseni (alogliptin and pioglitazone)

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From the Abstract for this new Annals of Pharmacotherapy article, published on January 30, 2019, we get the following:

• Objective: This meta-analysis aims to elucidate the risk for [inflammatory bowel disease (IBD)] with DPP-4 inhibitor therapy.
• Results: A total of 16 individual studies evaluating a total of 198 404 patients were included for analysis. Studies ranged from 52 weeks through 5 years. In the primary random-effects analysis, DPP-4 inhibitor exposure resulted in a nonsignificant increase in the risk of [inflammatory bowel disease (IBD)] (RR = 1.52; 95% CI = 0.72 to 3.24; I2 = 54.2%).... DPP-4 inhibitor use significantly increased the risk of [Crohn's disease (CD)] (RR = 2.47; 95% CI = 1.36 to 4.48)....
• Conclusion and Relevance: Based on a conservative random-effects analysis, DPP-4 inhibitors do not appear to increase the risk of developing inflammatory bowel disease. However, long-term postmarketing surveillance is warranted.

In summary, this recent study found that the DPP-4 inhibitor class of drugs is not associated with IBD; however, DPP-4 inhibitor diabetes drugs, such as Januvia and Onglyza, increase the risk of Crohn's disease (CD).

Be assured that we will continue to monitor the safety profile of these DPP-4 diabetes drugs.

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Number Of Eliquis Lawsuits Filed Across The Country Is Increasing, But This Drug Injury Litigation Is Still In Its Early Stages

Eliquis Has Caused Irreversible Bleeding Events, Such As Trauma Incidents And Hemorrhagic Strokes, Which Can Be Life-Threatening And Sometimes Fatal

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Eliquis (apixaban) was approved by the FDA in December 2012. Pfizer and Bristol-Myers Squibb are the two drug companies responsible for Eliquis.

It is important to know that as of September 2016 Eliquis does not currently have an FDA-approved antidote, or reversal agent, for a patient experiencing a trauma-induced bleeding event or needing emergency surgery.

These serious medical conditions have been associated with the use of Eliquis:

• Serious Bleeding Events
• Irreversible Fatal Bleeding Events
• Trauma-induced Atypical Bleeding Incidents
• Gastrointestinal (GI) Bleeds
• Rectal Bleeding
• Hemorrhages
• Brain Hemorrhage
• Intracranial Hemorrhage
• Hemorrhagic Stroke
• Cardiac Bleeds

 

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 Eliquis  ---  Savaysa  ---  Xarelto

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While an Eliquis antidote will someday be available to help patients suffering an acute bleed, unfortunately, it is too late for some people who suffered serious bleeding events or bled to death, already.

Our law firm is handling Eliquis cases which involve people who had excessive bleeding, bled to death, or experienced other serious side effects of Eliquis.

In recent months we have seen Eliquis lawsuits filed in various states across the country, from New York to Hawaii, from California to Kentucky, from Illinois to Louisiana, as well as in Pennsylvania and elsewhere. We estimate that less than 50 Eliquis lawsuits have been filed to date. That relatively low number of filed Eliquis cases, however, is expected to increase significantly in the months to come.

We will monitor the Eliquis litigation as it develops and, of course, will report noteworthy events as they happen.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb) 

Blood Thinner Pradaxa Linked To More Cases Of Serious Bleeding Events And New FDA Study Confirms Increased Risk Of GI Bleeds Compared To Warfarin

More Than 2000 Pradaxa Lawsuits Have Been Filed Against Boehringer, And A Company Official Has Admitted That More Than 1400 Patients Bled To Death

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: Boehringer Pays $650 Million to End Blood Thinner Cases (5/28/14, Bloomberg)

Boehringer Ingelheim GmbH, the German family-owned drugmaker, agreed to pay $650 million to settle the majority of lawsuits filed over its blood-thinning drug Pradaxa, which has been linked to more than 500 patient deaths....

(5/28/14)

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Earlier this month the drug company Boehringer Ingelheim said a new analysis of a company-funded study of 18,000-patients, known as RE-LY -- which the company used to win FDA approval of its controversial blood thinner Pradaxa -- turned up 22 "new" serious bleeding events that were not included in the original study report.

According to a May 14, 2014 news article, "Boehringer Says New Bleeding Cases Found in Pradaxa Study":

Any correction to the original study, which was published in the New England Journal of Medicine in September 2009, would have to come from the researchers, Smith said. If a correction is made, it would be the second to the trial.

The researchers issued a correction in November 2010, saying they identified several additional events when they were conducting “routine clinical site closure visits.” A broader review at the time found 81 more complications, including clots, major bleeding, a stroke and four heart attacks, in 80 patients.

Further, from that same May 2014 Bloomberg article:

Boehringer faces more than 2,000 lawsuits involving Pradaxa, a treatment used to prevent strokes in patients who suffer from atrial fibrillation, a heart-rhythm disorder. The Ingelheim, Germany-based company conducted the review after plaintiff’s attorneys uncovered patients who experienced major bleeding and died while taking Pradaxa who weren’t included in the original trial results....

More than 1,400 patients bled to death while taking the medicine through Oct. 2, 2013, Andreas Clemens, an executive who oversaw the drug, said in a deposition unsealed Feb. 19 as part of the lawsuits.

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Also in mid-May 2014 the FDA issued a follow-up to its Pradaxa Drug Safety Communication issued on November 2, 2012, and the FDA has reiterated that Pradaxa is associated with an increased risk of major gastrointestinal (GI) bleeding compared to warfarin.

From this Pradaxa safety update item, "FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin", issued on May 13, 2014:

FDA completed an observational cohort study of Medicare beneficiaries that compared Pradaxa (dabigatran) and warfarin for rates of ischemic stroke, intracranial hemorrhage, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The study included new users of Pradaxa and warfarin who had received a diagnosis of atrial fibrillation (AF) in the 6 months prior to the first dispensing of medication....

The larger Medicare study, which assessed a relatively older population (all over 65 years of age) found that Pradaxa was associated with an increased risk of major GI bleeding compared to warfarin. This finding is consistent with the RE-LY trial which showed that the risk of GI bleeding with Pradaxa compared to warfarin increased with age.

We will continue to monitor the FDA regulatory realm, the products liability litigation, and the medical research literature for developments about the safety issues surrounding Pradaxa, especially those involving cases of gastrointestinal (GI) bleeding adverse drug events, some which have been fatal to patients.

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DrugInjuryLaw.com: Current Legal And Medical Information About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Legal case review done by attorney Tom Lamb)

Benicar (Olmesartan) Associated With Sprue-Like Enteropathy, Which Is A Chronic / Severe Diarrhea Condition That Can Be Misdiagnosed As Celiac Disease

This Diarrhea With Weight Loss Is Also A Side Effect Of Benicar HCT, Azor, And Tribenzor -- Other Blood Pressure Medicines Containing Olmesartan

(Posted by Tom Lamb at DrugInjuryWatch.com)

An association between the serious side effect sprue-like enteropathy and the oral angiotensin-receptor blockers (ARBs) Benicar, Benicar HCT, Azor, and Tribenzor and has been getting increased attention in the medical literature.

As pointed out by the FDA in July 2013 when it issued this MedWatch alert, "FDA Drug Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil", severe and chronic diarrhea with substantial weight loss has been reported in patients taking Benicar and the other related drugs months to years after they first started using these blood pressure pills.

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The most recent medical article we have seen on this still emerging drug safety issue was published online by the Journal of Pharmacy Practice in late March 2014.  From the Abstract for "A Review of Current Evidence of Olmesartan Medoxomil Mimicking Symptoms of Celiac Disease" we get this information:

Objective: To review the evidence of an association between [Benicar, Benicar HCT, Azor, and Tribenzor (olmesartan medoxomil)] and symptoms mimicking celiac disease....

Data Sources: Literature was searched in PubMed (1965-November 2013) using the key words or MeSH terms olmesartan, enteropathy, celiac disease, sprue, and diarrhea.

Data Synthesis: There have been recent implications of [Benicar, Benicar HCT, Azor, and Tribenzor (olmesartan medoxomil)] being linked to symptoms mimicking celiac disease. Investigators first identified the association in 22 patients who presented with presumed refractory celiac disease. Upon further evaluation, it was discovered that these symptoms improved when [Benicar, Benicar HCT, Azor, or Tribenzor (olmesartan medoxomil)] was discontinued. In response to this report, additional case studies have been published.

Conclusions: There is growing evidence supporting the association between [Benicar, Benicar HCT, Azor, and Tribenzor (olmesartan medoxomil)] and sprue-like symptoms; however, further research is warranted. These symptoms can be life threatening and clinicians should be aware of the potential association.

For more information you can take a look at our previous articles:

• Benicar-Induced Enteropathy: Recently Found / New Possible Cause Of Villous Atrophy: Symptoms And Diagnosis
• Blood Pressure Drug Benicar Causes Serious Intestinal Side Effects Such As Chronic And Severe Diarrhea Months Or Years After Starting Drug

Of course, we are continuing to monitor this drug safety issue concerning Benicar, Benicar HCT, Azor, and Tribenzor.

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DrugInjuryLaw.com: Current Legal And Medical Information About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Legal case review done by attorney Tom Lamb)