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FDA Approves Boxed Warning on Xeljanz (Tofacitinib)

Xeljanz FDA Warning

The US Food and Drug Administration approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR), which is used in patients with ulcerative colitis.

This new warning, issued July 26, 2019, comes just a few months after the first warning issued February 25, 2019.


FDA Drug Safety Communications

In February, the FDA issued a warning alerting the public about a safety clinical trial that 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 dose for rheumatoid arthritis; it is only approved in the dosing regimen for patients with ulcerative colitis.]

According to the FDA alert, this ongoing safety trial required by the FDA when it approved tofacitinib for RA, the drug manufacturer, Pfizer, is transitioning patients who were on the high 10 mg twice daily dose to the lower, currently approved dose of 5 mg twice daily. This trial is expected to be completed by the end of 2019.

In July, the FDA issued another warning, adding its most prominent Boxed Warning after reviewing interim data from this ongoing safety clinical trial.


FDA Approvals of Tofacitinib

  • In 2012, the FDA approved the use of tofacitinib to decrease immune system activity in patients with rheumatoid arthritis (RA) who did not react favorably to the medication methotrexate.
  • In 2017, approval was given for the medication to be used for psoriatic arthritis (PsA) patients who did not respond well to methotrexate or similar medications.
  • The following year, the medication was approved to treat ulcerative colitis.

Postmarketing Clinical Trial

When the FDA first approved tofacitinib, a postmarketing clinical trial in patients with RA on background methotrexate was required to evaluate the risk of heart-related events, cancer, and infections.

The trial is studying two different doses of tofacitinib (5 mg twice daily, which is the currently approved dose for RA, and a higher, 10 mg twice daily dosage) in comparison to a TNF blocker.

An interim analysis of the trial’s results found an increased occurrence of blood clots and of death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF blocker. Based on these results, the 10 mg twice daily treatment was stopped and patients were allowed to continue treatment on 5 mg twice daily.


Talk to Your HealthCare Professional

An overactive immune system contributes to RA, PsA and ulcerative colitis. Tofacitinib works by decreasing the activity of the immune system.

In RA, the body attacks its own joints, causing pain, swelling, and loss of function. PsA also causes joint pain and swelling and ulcerative colitis is a chronic, inflammatory disease affecting the colon.

Given these warnings, the approved use of the medication for ulcerative colitis will be restricted to patients for whom other medications do not provide effective treatment or who experience serious side effects.

Patients who have a history of blood clots or heart problems should talk to their health care professionals, especially if you experience unusual symptoms that could indicate a blood clot:

  • 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

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