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.
UPDATE: Black Box Warning for Blood Clots & Death
The FDA has added a Boxed Warning on Xeljanz regarding the increased risk of blood clots and death from the 10-mg twice-daily dose. Patients should stop taking Xeljanz and seek emergency medical attention if they develop symptoms of a blood clot, such as:
- Sudden shortness of breath
- Chest pain that worsens with breathing
- Swelling of a leg or arm
- Leg pain or tenderness, or red or discolored skin in the painful or swollen leg or arm
Xeljanz Linked to Blood Clots and Death
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 and Rheumatoid Arthritis
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.
Xeljanz Safety Study
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.
Safety Committee Finds Higher Risk for Pulmonary Embolism and Death
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.
FDA: Doctors Should Prescribe Recommended Doses of Xeljanz
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.
What Should I Do?
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.
Warning Signs & Symptoms of Pulmonary Embolism
- Sudden trouble breathing
- Shortness of breath
- Chest pain (or back pain)
- Coughing up blood
- Severe sweating
- Skin that is clammy or bluish-colored