Xeljanz® is an arthritis drug that is linked to an increased risk of blood clots in the lungs (pulmonary embolism) and death when it is prescribed at high doses.
UPDATE: Boxed Warning for Xeljanz, Blood Clots & Death
The FDA has added a Boxed Warning label on Xeljanz to warn about the increased risk of blood clots and death with the 10-mg twice-daily dose.
Patients should to 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 in Lungs and Death
February 25, 2019 — The FDA is warning that an ongoing safety study has found an increased risk for blood clots in the lungs (pulmonary embolism) and death when Xeljanz® is prescribed at 10-mg twice-daily doses to 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 10-mg twice-daily dose of Xeljanz is only approved for patients with ulcerative colitis — it is NOT approved for patients with arthritis. Therefore, the FDA is urging doctors to only prescribe Xeljanz at recommended doses.
What is Xeljanz?
Xeljanz® (tofactinib) is a medication manufactured by Pfizer that was approved for rheumatoid arthritis in 2012. It alleviates symptoms of arthritis by decreasing the activity of the immune system. It works by stopping the immune system from attacking the joints and causing severe pain, swelling, and loss of function.
FDA Requires Xeljanz Safety Study
When the FDA approved Xeljanz, Pfizer was required to conduct a post-marketing safety study to investigate the risk of heart-related events, cancer, and certain infections. All of the patients in the study were over 50 years old and had at least 1 cardiovascular risk-factor.
Study Finds Risk for Blood Clots and Death
The increased risk of death and blood clots was discovered in an analysis of the post-marketing study by an external safety committee. The data showed higher rates of death and pulmonary embolism (blood clots in the lungs) among patients on Xeljanz 10-mg twice-daily compared to patients on Xeljanz 5-mg twice-daily or a TNF inhibitor.
What Should I Do?
Doctors should monitor patients for warning signs and symptoms of blood clots or a pulmonary embolism. Patients should seek emergency medical attention if they develop any of these symptoms.
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