Xeljanz is a prescription medication marketed by Pfizer to treat adults with moderate to severe rheumatoid arthritis and was approved by the Food and Drug Administration (FDA) in 2012. Patients are typically prescribed methotrexate for serious arthritic conditions. Xeljanz is intended for those who have had an inadequate response or intolerance to methotrexate. As a condition of approval by the FDA, Pfizer was required to conduct a safety trial to determine the risk of side effects, such as an increased risk of serious infections.

A Dangerous Drug

A clinical trial found an increased risk of pulmonary embolism, or blood clots in the lungs, and death in rheumatoid arthritis sufferers who were prescribed 10 mg twice-daily dosage. The FDA has not approved a 10-mg twice-daily dose for the treatment of rheumatoid arthritis. According to the FDA safety announcement, Pfizer has been instructed to transition participants in the trial “who were on the high 10 mg twice daily dose to the lower, currently approved dose of 5 mg twice daily”.

Serious Health Problems

A pulmonary embolism is a life-threatening condition that occurs when a blood clot occurs in the lung. The condition constitutes a medical emergency that requires immediate treatment. Symptoms, such as difficulty breathing, sharp pains in the chest, heavy sweating, a racing heartbeat or coughing up blood or pink, foamy mucus that come on suddenly and without explanation, could all be indications of a pulmonary embolism. A blood clot in the lung restricts blood flow and decreases oxygen levels which can permanently damage the lungs and other organs. Such a blockage can be fatal. According to the Mayo Clinic, a pulmonary embolism results in death in a full one-third of people who go undiagnosed or untreated.

What can you do?

If you or someone you know was prescribed 10 mg twice daily of Xeljanz or Xeljanz XR for rheumatoid arthritis and has suffered a pulmonary embolism (blood clot in the lungs) or has died as a result, please contact the lawyers at Baron & Budd or call (866) 340-2545 for a free and confidential case evaluation.

Sources:

https://www.fda.gov/Drugs/DrugSafety/ucm631871.htm
https://ra.xeljanz.com/about-xeljanz/what-is-xeljanz
https://www.schmidtlaw.com/xeljanz-lawsuit/
https://www.pfizer.com/products/product-detail/xeljanz
http://labeling.pfizer.com/ShowLabeling.aspx?id=959
https://www.pfizermedicalinformation.com/en-us/xeljanz
https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php
https://www.healthline.com/health/pulmonary-embolus
https://www.businesswire.com/news/home/20160224006053/en/Pfizer-Announces-FDA-Approval-XELJANZ%C2%AE-XR-tofacitinib