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Clinical Trial Links Xeljanz to Pulmonary Embolism
During a post-marketing clinical trial , Xeljanz was found to significantly increase the risk of a blood clot forming and then traveling to the lungs, especially when taken at a high dose.
The study, which looked at a cohort of 4,400 participants, all of whom had at least one cardiovascular risk factor, was designed to test the efficacy and safety of Xeljanz compared to a tumor necrosis factor (TNF) inhibitor medication in patients with rheumatoid arthritis, or RA. The trial sought to determine whether Xeljanz was more or less safe for patients with increased cardiovascular risks, and monitored their heart health and whether they developed malignancies or cancer.
Halfway through the trial, Pfizer intervened to take participants off of the twice-daily dose of 10 milligrams after a disturbingly high number of patients at that dosage were developing blood clots in their lungs and suffering pulmonary embolism.
Patients using the high dosage of Xeljanz were developing PE more than 5 times as often as patients taking the TNF inhibitor. They were also suffering pulmonary embolism 3 times more than patients who were taking lower doses of Xeljanz.
Following the notification, Pfizer shifted participants from the twice-daily 10-milligram dose to the twice-daily 5-milligram dosage level. The move was likely prompted by the U.S. Food and Drug Administration's prior announcement about Xeljanz, which warned the public of the potential for pulmonary embolism after taking the drug. FDA’s announcement was published on Feb. 25, 2019.
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What Causes a Pulmonary Embolism?
A pulmonary embolism refers to a blood clot that blocks blood flow to the lungs. In most patients, the clot starts in a leg and travels to the lung. In rare cases, the clot forms in a vein in another part of the body. When a blood clot forms in one or more of the deep veins in the body, it's called a deep vein thrombosis, or DVT.
Because clots block blood flow to the lungs, PE can be fatal. However, prompt treatment greatly reduces the risk of death. Taking measures to prevent blood clots in your legs will help protect you against pulmonary embolism.
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