Pfizer’s arthritis drug Xeljanz® increases the risk of death and blood clots in the lungs (pulmonary embolism) when it is prescribed at 10-mg twice-daily doses to patients with rheumatoid arthritis.
The Monsour Law Firm is currently accepting Xeljanz induced injury cases. If you or somebody you know has been diagnosed with blood clots or suffered death after taking Xeljanz, you should contact our lawyers immediately for a free case consultation.
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February 2019 — The FDA has issued a Safety Announcement to warn that 10-mg twice-daily doses of Xeljanz increases the risk for death and life-threatening blood clots in the lungs of patients with rheumatoid arthritis.
“A safety clinical trial found an increased risk of blood clots in the lungs and death when a 10-mg twice-daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA).”
The FDA has not approved this 10-mg twice-daily dose for the treatment of rheumatoid arthritis. This dose is only approved in the dosing regimen for patients with ulcerative colitis.
Xeljanz® (tofactinib) was approved by the FDA for the treatment of rheumatoid arthritis in 2012. It works by decreasing the activity of the immune system. In patients with rheumatoid arthritis, the immune system attacks its own joints, causing severe pain and swelling.
As a condition of approval, the FDA required Pfizer to conduct a study to investigate the risk of possible side effects like heart-related events, cancer, and certain infections.The study involved patients who were at least 50 years old with at least one cardiovascular risk-factor.
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During the analysis of the study, an external safety-monitoring committee found an increased risk of death and blood clots in the lungs (pulmonary embolism) in patients who were taking Xeljanz (10-mg) twice-daily compared to to patients who were taking Xeljanz (5-mg) twice-daily or a TNF inhibitor.
The FDA urges doctors to prescribe Xeljanz at the recommended doses. The 10-mg twice-daily dose that is linked to blood clots and death is NOT approved for rheumatoid arthritis patients – however, it is approved for patients with ulcerative colitis.
Doctors should also watch patients for signs and symptoms of blood clots or pulmonary embolism. Patients should be instructed to seek medical care immediately if these symptoms occur, the FDA warned.
The Monsour Law Firm is currently accepting Xeljanz induced injury cases. If you or somebody you know has been diagnosed with blood clots or suffered death after taking Xeljanz, you should contact our lawyers immediately for a free case consultation.
Douglas C. Monsour, or Doug Monsour, is a trial lawyer who handles important and significant injury cases in Texas and across the nation. He is one of a handful of trial lawyers who have successfully tried multiple pharmaceutical, medical device, and mass tort product liability cases as the lead lawyer. He also vigorously represents injured oil field workers, victims of 18-wheeler wrecks, industrial accident victims, and those that have been severely burned.
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In Texas, the statute of limitations for most personal injury cases is two years from the date of the injury. In Louisiana, it is generally one year. It’s essential to act quickly and consult with an attorney to ensure your claim is filed within the legal timeframe.
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This page has been written, edited, and reviewed by a team of legal writers following our comprehensive editorial guidelines. This page was approved by Founding Partner, Doug Monsour who has more than 20 years of legal experience as a personal injury attorney.
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