Xeljanz (Tofacitinib) Linked to Pulmonary Embolism or Blood Clots in Lungs

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Jeffrey Johnson is a legal writer with a focus on personal injury. He has worked on personal injury and sovereign immunity litigation in addition to experience in family, estate, and criminal law. He earned a J.D. from the University of Baltimore and has worked in legal offices and non-profits in Maryland, Texas, and North Carolina. He has also earned an MFA in screenwriting from Chapman Univer...

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UPDATED: Jul 15, 2021

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A recent analysis of a clinical trial for the drug Xeljanz has shown an increased risk of pulmonary embolism for individuals taking doses of 10mg or higher, two times a day, prompting the FDA to issue a Safety Alert in February 2019 regarding the risks.

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Xeljanz and the Clinical Trial

Xeljanz (pronounced “zell-janz”) and Xeljanz XR are the product names for the drug tofacitinib. Xeljanz is used to treat rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis, and comes in pill form, which is an improvement for patients who otherwise might require injections. Xeljanz is also an expensive drug, costing some patients as much as $50,000 per year. It is reported that Pfizer, the drug company behind Xeljanz, generated $1.77 billion in sales from the drug in 2018 alone.

The FDA first approved the use of tofacitinib in 2012 for the treatment of rheumatoid arthritis. At the time, the FDA required a clinical trial be conducted for patients with rheumatoid arthritis to determine the risks of heart-related events, cancer, and infections at the 10mg and 5mg daily dosages. The trial is ongoing and due to be completed at the end of 2019.

Some doctors have prescribed Xeljanz for off-label uses, such as to try to regrow hair on people suffering from alopecia, as there was a report that one alopecia patient who had been taking the drug unexpectedly regrew hair.

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Xeljanz and Increased Risk of Blood Clots in Lungs

A recent analysis, however, has indicated that the 10mg dosage is causing a higher incidence of pulmonary embolism, or a blood clot in an artery that goes from the heart to the lungs, in trial participants. Other studies have raised concerns about the use of Xeljanz and an increased risk for strokes and deep vein thrombosis (DVT). DVT can cause leg pain or swelling, but also can occur with no symptoms in one of the deep veins of the body in people who are taking or have taken Xeljanz. 

The blood clots caused by the drug – whether a single clot that becomes so large that it completely cuts off the blood flow in an artery, or multiple small clots that combine to block off an artery, such as the one that goes from the heart to the lungs – have caused serious results, including serious damage to patients’ lungs, harm to multiple organs, and even deaths.

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If You Are Taking Xeljanz

The FDA recommends that patients taking Xeljanz not stop using the medication without first talking to their healthcare provider, but seek immediate medical attention if they are experiencing symptoms indicating a blood clot in the lungs, or any of the following:

  • Sudden shortness of breath or difficulty breathing
  • Chest or back pain
  • Coughing up blood
  • Excessive sweating
  • Clammy or bluish colored skin

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Legal Action for Injury or Wrongful Death

Lawyers and the experts who have investigated Xeljanz now believe that it may be possible for individuals who were injured as a result of taking the drug (and their family members), or the family members of those who were killed as a result of taking the drug, to recover significant damages from Pfizer and possibly others.

Advocate Law Group represents injured patients in claims against the manufacturers and distributors of pharmaceutical drugs. You may be entitled to compensation if you were diagnosed with pulmonary embolism after taking high dosages of Xeljanz , but you should contact Advocate Law Group promptly to avoid losing your right to seek a legal remedy for your condition.


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