Xeljanz is a medication that is linked to an increased risk of blood clots and death when it is prescribed at high doses to patients with rheumatoid arthritis.
New Warnings Added for Blood Clot & Death Risk
July 2019 — The FDA has added a Boxed Warning label on Xeljanz about an increased risk of blood clots and death with the 10-mg twice-daily dose of Xeljanz and Xeljanz XR (tofacitinib).
Patients should stop taking Xeljanz and seek emergency medical attention right away if you experience any unusual symptoms, including 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 Higher Risk of Blood Clots, Pulmonary Embolism, Death
February 2019 — The FDA is warning about an increased risk of blood clots in the lungs (pulmonary embolism) and death in patients with rheumatoid arthritis who were prescribed twice-daily 10-mg doses.
High Dose of Xeljanz is Not Approved for Arthritis
The FDA has not approved this twice-daily 10-mg dose for rheumatoid arthritis. It is only approved for the treatment of ulcerative colitis. The FDA urges doctors to follow the recommendations in the prescribing guidelines for the specific disease they are treating.
Symptoms of a Pulmonary Embolism
Patients should not stop taking Xeljanz without first consulting a doctor because doing so could worsen their condition. Patients taking Xeljanz should seek emergency medical attention if they develop 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?
Xeljanz® and Xeljanz XR® (generic: tofacitinib) are medications that are sold by Pfizer for the treatment of diseases such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. These diseases occur when the body is attacked by its own over-active immune system. Xeljanz works by decreasing the activity of the immune system.