FDA Adds Boxed Warning for Blood Clots & Death
In July 2019, the FDA has updated the label on Xeljanz and Xeljanz XR with a Boxed Warning about an increased risk of blood clots and death from the 10-mg twice-daily dose.
The FDA recommends that patients stop taking Xeljanz and seek emergency medical attention for 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
Study Links Xeljanz and Blood Clots, Death
In February 2019, the FDA published a Safety Warning after a study found that patients with rheumatoid arthritis who were prescribed a twice-daily 10-mg dose of Xeljanz had a higher risk for blood clots in the lungs (pulmonary embolism) and death.
FDA: High Dose is Not Approved for Arthritis
The twice-daily 10-mg dose is only FDA-approved for ulcerative colitis — it is not approved for rheumatoid arthritis. Due to the increased risk for life-threatening side effects, the FDA is urging doctors to follow dosage recommendations for the specific disease they are treating.
Patients Should Be Vigilant for Symptoms of Pulmonary Embolism
Patients on Xeljanz should be vigilant for symptoms of a pulmonary embolism. They should seek emergency medical attention for symptoms of a blood clot in the lungs, such as:
- Sudden shortness of breath or difficulty breathing
- Chest pain or pain in your back
- Coughing up blood
- Excessive sweating
- Clammy or bluish colored skin
What is Xeljanz?
Pfizer sells the medications Xeljanz® and Xeljanz XR® (generic: tofacitinib) for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Xeljanz decreases the activity of the immune system, which stops the immune system from over-reacting and attacking the body.