Entyvio (vedolizumab) is a treatment for ulcerative colitis or Crohn’s disease that is linked to Interstitial Lung Disease, a life-threatening side effect that can cause severe breathing problems.
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What is Entyvio?
Entyvio (vedolizumab) is a treatment for adults with moderate-to-severe ulcerative colitis or Crohn’s disease. It was developed by Takeda Pharmaceuticals and approved in the U.S. in May 2014.
What is the Problem?
Doctors have published a growing number of case reports of patients who developed interstitial lung disease after receiving Entyvio. In some patients, it only took a couple doses of Entyvio before they developed a severe lung injury, including one patient in China who died of interstitial lung disease after only 2 doses of Entyvio.
Label on Entyvio Does Not Include Warnings About Lung Disease
The problem is that the label on Entyvio does not include any warnings about the risk of lung disease. The reports in the medical literature are rare, but they are very serious — and if a doctor is not aware of the risk, it can delay a proper diagnosis until the patient is very sick, which increases the risk of deadly complications.
What is Interstitial Lung Disease?
Interstitial Lung Disease (ILD) is an umbrella term for a large group of diseases that cause scarring (called “fibrosis”) in the lungs, according to the American Lung Association. The scarring causes the lungs to stiffen, which makes it harder for them to transport oxygen to the body. The lung damage and scar tissue is permanent, and it often gets worse over time, which can lead to deadly complications.
Symptoms of Interstitial Lung Disease
- Shortness of breath
- Dry cough
- Chest discomfort or pain
- Weight loss
- High blood pressure
- Heart failure
- Respiratory failure
Case Reports Linking Entyvio and Lung Disease
- February 2022 — Vedolizumab-associated diffuse interstitial lung disease in patients with ulcerative colitis: A case report: The first case report of a death involving Entyvio and lung disease — A man in China developed a fever, cough, and was diagnosed with “severe diffuse interstitial lung disease” after 2 doses of Entyvio
- December 2021 — Vedolizumab-induced acute interstitial lung injury in a 39-year-old male with ulcerative colitis: 39-year-old man took Entyvio and developed an “acute severe interstitial lung injury” that required discontinuing Entyvio and treatment with systemic steroids.
- February 2021 — Crohn’s Disease with Atypical Extra-Intestinal Manifestations Developing Under Treatment with Vedolizumab: Case report of a patient who developed “granulomatous lung disease” after being treated with Entyvio. His doctors also theorized on how Entyvio could cause lung disease: “Our case may add evidence to the emerging theory that gut-selective biologic agents could lead to upregulation of some pro-inflammatory factors leading to the evolution of pulmonary disease.”
- September 2019 — New-Onset Diffuse Parenchymal Lung Disease in a 52-Year-Old Woman With Ulcerative Colitis: Case report of a 52-year-old woman who was on Entyvio for 2 years before she developed parenchymal lung disease.
- January 2018 — Pulmonary Manifestation of Crohn’s Disease Developed Under Treatment With Vedolizumab: 28-year-old patient on Entyvio was diagnosed with shortness of breath, dry cough, lung fibrosis and inflammation.
Diagnosis for Lung Disease
To diagnose interstitial lung disease, doctors may need to order a chest X-ray or a CT scan to get a better look at the lungs. They may use a “lung function test” measure lung capacity. Some patients may need a more invasive test, such as a lung biopsy or bronchoscopy.
Treatment for Lung Disease
Interstitial lung disease is permanent and it gets worse over time, so treatment normally focuses on relieving symptoms and slowing the progression of the disease. Patients may need to take anti-inflammatory corticosteroid medications, or receive oxygen therapy.
Will I Need Oxygen Therapy?
One of the most common treatments for lung disease is oxygen therapy, which is when a person breathes extra oxygen through a face mask or nasal prongs from a tank. This makes it easier to breathe and increases blood oxygen levels, which can help treat serious complications related to low blood-oxygen levels, like heart failure and fatigue.
Need an Entyvio Lawyer in Texas?
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