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Study Suggests Increased Blood Clot Risk with Xeljanz
An ongoing post-marketing study of Xeljanz and Xeljanz XR identified a statistically significant rate of pulmonary embolism for rheumatoid arthritis (RA) patients using the 10 mg twice daily dose of Xeljanz compared to a control group given tumor necrosis factor inhibitors (TNFis), a different group of RA drug.
The study also found an increased risk of death compared to participants taking the 5 mg twice daily dose and in the control group. FDA required this safety study to be performed when it originally approved Xeljanz in 2012.
After finding the increased risk of pulmonary embolism in subjects taking the higher dose of Xeljanz, the study’s Data Safety Monitoring Board (DSMB) required those patients to be treated with the lower dose.
In Feb. 2019, FDA released a safety announcement about the increased risk of pulmonary embolism and death in RA patients taking the 10 mg twice daily dose of Xeljanz or Xeljanz XR. The agency stated it is “working with the manufacturer to evaluate other currently available safety information for tofacitinib and will update the public with any new information based on…ongoing review.”
Pulmonary Embolism Symptoms
Symptoms of a blood clot in the lung can vary greatly from patient to patient, depending on how much of the lung is involved, the size of the clot, and whether the patient has an underlying disease or health condition.
Common symptoms of a pulmonary embolism include:
- Shortness of breath
- Chest pain
Other symptoms that can occur in patients with a blood clot in the lung include:
- A cough that may include bloody or blood-streaked mucus
- Rapid or irregular heartbeat
- Lightheadedness or dizziness
- Excessive sweating
- Leg pain or swelling, or both, usually in the back of the lower leg
- Clammy or discolored skin (cyanosis)
Pulmonary embolism is usually treated in a hospital setting, where the condition can be monitored closely. The length of treatment and hospital stay will vary depending on the severity of the clot. The main treatment for a pulmonary embolism is an anticoagulant (blood thinner) drug.
Depending on the severity of the clot and its effect on the other organs, the patient may also be required to undergo thrombolytic therapy, surgery or interventional procedures to improve blood flow in their pulmonary arteries.
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The Pharmaceutical Litigation Group at our law firm is an experienced team of trial attorneys that focus on the representation of plaintiffs in Lawsuits. We are handling individual litigation nationwide and currently accepting new class action lawsuits against Xeljanz in all 50 states.
Free Lawsuit Evaluation: Again, if you were harmed after taking Xeljanz to treat rheumatoid arthritis, you should contact our attorneys immediately. Xeljanz patients may be entitled to a settlement for medical expenses by filing a class action lawsuit and our Attorneys can help.