XELJANZ CAUSING PULMONARY EMBOLISM LAWSUIT ATTORNEY

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.

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.

• Sudden trouble breathing
• Shortness of breath
• Chest pain (or back pain)
• Coughing up blood
• Severe sweating
• Skin that is clammy or bluish-colored

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.