Ulcerative colitis and Crohn’s disease patients taking Entyvio to control irritation and inflammation in the gastrointestinal (GI) tract may be at risk for serious lung issues that can be fatal. Case reports dating back several years suggest that Entyvio, considered a first-line treatment for adults with moderate to severe ulcerative colitis or Crohn’s disease, may increase the risk of interstitial lung disease, respiratory disease, and other serious and potentially life-threatening lung problems. Contact Consumer Safety Watch today to learn more about the possible side effects of the ulcerative colitis and Crohn’s disease drug, Entyvio.

Entyvio Lawsuit

Entyvio Lawsuit Information

A growing body of evidence suggests that Entyvio use among patients with ulcerative colitis (UC) or Crohn’s disease (CD) may lead to serious or potentially life-threatening lung injuries, including interstitial lung disease, or fibrosis of the lungs, a condition characterized by lung tissue scarring that can worsen over time and ultimately lead to death. The literature suggests that Entyvio use may lead to significant side effects after just two doses of the drug. This includes several recent case reports where inflammatory bowel disease patients treated with Entyvio suffered serious and irreversible adverse lung-related events and died due to respiratory failure.

There is evidence that Entyvio may help people with ulcerative colitis or Crohn’s disease achieve and maintain remission. In fact, while Entyvio was previously recommended only for patients who were unable to tolerate other medications, the latest guidelines advise that adults with moderate to severe UC or CD begin treatment with Entyvio (or another biologic medication) right away, and if remission occurs, continue using the drug as maintenance therapy. Unfortunately, there have been no warnings on the Entyvio label about the potential risk of interstitial lung disease or other pulmonary problems in patients taking the medication. People who developed lung-related injuries after taking Entyvio or the loved ones of those who died may be eligible to pursue financial compensation from Takeda Pharmaceuticals for medical bills, lost wages, and other losses.

Side Effects Associated with Entyvio

• Interstitial lung disease
• Fibrosis of the lungs
• Pulmonary disease
• Respiratory disease
• Granulomatous lung disease
• Wrongful death

What is Entyvio?

Entyvio (vedolizumab) is a prescription drug manufactured by Takeda Pharmaceuticals and used to treat moderate to severe ulcerative colitis or Crohn’s disease in adults. Ulcerative colitis and Crohn’s disease are both chronic inflammatory bowel diseases, but the conditions affect the bowel in different ways. While UC causes inflammation and ulcers in the colon and rectum, Crohn’s disease can cause inflammation in any part of the digestive tract, from the mouth to the anus. The symptoms of ulcerative colitis and Crohn’s disease can be painful and debilitating, ranging from pain and abdominal cramps to rectal bleeding and bloody diarrhea. Entyvio is designed to control inflammation and other symptoms of ulcerative colitis and Crohn’s disease by preventing an excess of white blood cells from entering into the GI tract. Entyvio is administered via intravenous infusion, given in three initial doses two and then six weeks apart, followed by a dose every eight weeks thereafter.

Reasons to File an Entyvio Lawsuit

Entyvio injury or wrongful death lawsuits may allege that:

• Takeda designed, manufactured, and sold a defective and unreasonably dangerous medication.
• The manufacturer failed to properly research the potential lung-related side effects of Entyvio.
• The manufacturer failed to provide adequate warnings to patients and healthcare providers about the possibility of Entyvio causing interstitial lung disease and other serious lung problems.
• The manufacturer knew or should have known about the potential for lung-related injuries from Entyvio and withheld this information from the public.
• Patients could have avoided serious lung injury or death had they been properly warned about the possible health risks.

History of Entyvio

Entyvio was approved by the FDA in 2014 as a treatment for ulcerative colitis and Crohn’s disease, when certain other drugs have not worked well enough or cannot be tolerated. While vedolizumab (Entyvio) has been recognized as an effective treatment for UC and CD, there have been growing concerns about the drug’s safety and possible adverse events. A potential link between Entyvio and serious pulmonary side effects emerged in case reports from 2018 detailing lung injuries in ulcerative colitis and Crohn’s disease patients treated with the medication. Since then, there have been a number of other case reports highlighting pulmonary disease and other lung issues that occurred during or after treatment with Entyvio, including one where a 31-year-old patient with small intestinal Crohn’s disease developed granulomatous lung disease while being treated with vedolizumab (Entyvio).

“We cannot be certain that there is a direct connection between treatment with vedolizumab and the emergence of the consolidations, although the chronological order of events strongly suggests this possibility,” the researchers wrote in the case report, published in February 2021. “The resolution of GI symptoms and the evolution of respiratory disease occurred directly after treatment with vedolizumab […].” In another case study from February 2022, a patient was diagnosed with vedolizumab-related interstitial lung disease after receiving two doses of the ulcerative colitis drug. The patient died of respiratory failure and the researchers concluded that “Vedolizumab-related interstitial lung disease in patients with UC is rare but potentially lethal.”

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