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Entyvio Side Effects & Ulcerative Colitis Lawsuit | Get the Right Lawyer

The ulcerative colitis drug Entyvio (generic: vedolizumab) has recently been linked to an increased risk for serious side effects including interstitial lung disease, fibrosis of the lungs, shortness of breath, pulmonary disease, and other serious lung problems.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt
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What is Entyvio?

Entyvio (vedolizumab) is a brand-name prescription medication typically used to treat moderate to severe ulcerative colitis (UC) or Crohn’s disease in people who don’t have enough improvement from other medications.

It is a biologic drug that belongs to a class of medications called integrin receptor antagonists that come as a solution given by intravenous (IV) infusion. Entyvio is manufactured by Takeda Pharmaceuticals, and was approved by the U.S. Food and Drug Administration (FDA) on May 20, 2014.

What’s the Problem?

Since its approval in 2014, there have been multiple case reports of severe lung disease and other serious side effects associated with Entyvio treatment.

Entyvio Side Effects

  • Interstitial lung disease
  • Fibrosis of the lungs
  • Shortness of breath
  • Other Lung/pulmonary problems
  • Progressive multifocal leukoencephalopathy (PML)
  • Cancer
  • Liver damage
  • Allergic reactions
  • Infusion reactions
  • Infections
  • Death

Other more moderate side effects of Entyvio may include:

  • Runny nose
  • Sore throat
  • Respiratory infections such as bronchitis or sinus infection
  • Headache
  • Joint pain
  • Nausea
  • Fever
  • Fatigue
  • Cough

Entyvio Case Studies and Statistics

  • According to a February 2021 case study, the Agency published in the European Journal of Case Reports in Internal Medicine that the patient with Crohn’s disease developed granulomatous lung disease while taking Entyvio. The researchers concluded that gut-selective biologic agents like Entyvio could lead to the upregulation of some pro-inflammatory factors, leading to the development of pulmonary disease. [1]
  • Another case was described by Lissner et al. of a 28-year-old patient with ulcerative colitis who had received 3 infusions of Entyvio. The patient subsequently developed respiratory problems and bilateral infiltrates on a chest CT scan. An open lung biopsy revealed non-caseating granulomas, while a repeat colonoscopy revealed similar granulomas in the GI tract, leading to a diagnosis of Crohn’s disease with atypical pulmonary disease under Entyvio treatment.
  • As claimed by the case report published in the World Journal of Clinical Cases (WJCC) in Feb. 2022, the Organization has presented a case of new-onset parenchymal lung disease that occurred in a patient treated with Entyvio. After 2 doses of the drug, he developed persistent fever and progressively worsening dyspnea. The patient was subsequently diagnosed with vedolizumab-induced interstitial lung disease and later died from respiratory failure. [2]
  • In 2017, Sudheer et al. reported on a 58-year-old white man with ulcerative colitis who developed acute respiratory distress syndrome requiring intubation after receiving 3 doses of Entyvio. By withholding the drug and applying a steroid, the patient was successfully discharged home.
  • It has been reported that the sensitivity of mNGS for pathogen detection was 97.1%, with a negative predictive value of 94.1%

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What is Interstitial Lung Disease?

Interstitial lung disease (ILD) is an umbrella term used for a large group of diseases that cause scarring (fibrosis) of the lungs. The scarring causes stiffness in the lungs which makes it difficult to breathe and get oxygen to the bloodstream. Lung damage from ILDs is often irreversible and gets worse over time.

Pulmonary parenchymal diseases are rare in Crohn’s disease but they can be debilitating and life-threatening as they are usually tardily diagnosedNational Center for Biotechnology and Information

Interstitial Lung Disease Symptoms

  • Shortness of breath
  • Dry cough
  • Chest discomfort
  • Fatigue
  • Weight loss

What is Ulcerative Colitis?

Ulcerative colitis is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops tiny open sores or ulcers. The condition is the result of the immune system’s overactive response.

Signs and symptoms of ulcerative colitis include loose and urgent bowel movements, bloody stool, abdominal cramps/pain, and persistent diarrhea accompanied by abdominal pain and blood in the stool.

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Is There a Warning About Lung Problems on the Entyvio Labeling?

There is no mention on the Entyvio warning label of any lung or pulmonary problems.

What Should I Do If I’m Taking Entyvio?

If you develop serious side effects during Entyvio treatment, call your doctor right away. If the side effects seem life-threatening or if you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Get a Free Entyvio Lawsuit Evaluation With Our Lawyers

The Pharmaceutical Litigation Group at  Schmidt & Clark, LLP our law firm is an experienced team of jury trial lawyers that focus on the representation of plaintiffs in Entyvio Lawsuits. We are handling individual litigation nationwide and currently accepting new Entyvio side effects cases in all 50 states.

Free Confidential Entyvio Lawsuit Evaluation: Again, if you or a loved one suffered from Entyvio side effects, you should contact our law firm immediately. You may be entitled to financial compensation by filing an Entyvio lawsuit and our lawyers can help.



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