FDA to Require New Boxed Warning Label on Arthritis, Ulcerative Colitis Drugs Xeljanz® and Xeljanz XR®

In a September 1 announcement, the U.S. Food and Drug Administration (FDA) announced it will now be requiring an updated boxed warning label to be placed on the arthritis and ulcerative colitis drugs Xeljanz® and Xeljanz XR® (tofacitinib) — two drugs manufactured by Pfizer, Inc. The boxed warning label is the FDA’s most prominent warning.

The FDA’s decision comes promptly after a large, randomized clinical study showed the two Xeljanz drugs to increase the risk of adverse heart-related events, including heart attack and stroke. In the study, which observed patients with rheumatoid arthritis, the FDA compared Xeljanz against another set of arthritis drugs called “tumor necrosis factor” (TNF) blockers.

In the comparison, the FDA found that Xeljanz — even at low doses — demonstrated an increased risk of severe health side effects. The new findings build on previous, smaller trial results that identified such risks to be associated with higher doses of the medications.

The FDA writes:

“We have concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib).”

The FDA recommends that patients taking Xeljanz or Xeljanz XR discuss with their healthcare provider the newly identified risks associated with these drugs. Additionally, the agency recommends that patients seek emergency help right away if they experience any symptoms that may indicate a heart attack, stroke, or blood clot.

These symptoms include:

  • Discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • Severe tightness, pain, pressure, or heaviness in chest, throat, neck, or jaw
  • Unusual pain or discomfort in arms, back, neck, jaw, or stomach
  • Shortness of breath with or without chest discomfort
  • Breaking out in a cold sweat
  • Nausea or vomiting
  • Feeling lightheaded
  • Weakness in one part or on one side of you body
  • Slurred speech
  • Drooping on one side of your mouth
  • Swelling of a leg or arm
  • Leg pain or tenderness, or red or discolored skin in the painful or swollen leg or arm

Along with Xeljanz, the FDA’s warning includes two other drugs in the Janus kinase (JAK) inhibitors class, including Olumiant® (baricitinib) and Rinvoq™ (upadacitinib). Though these specific drugs have not yet been studied in larger clinical trials, as with Xeljanz, the FDA has identified that these medications may carry similar risks, because they share fundamental properties.

In the meantime, the FDA recommends that health care professionals update their risk profile of Xeljanz accordingly, and only prescribe these medications to patients for whom the potential benefits outweigh the risks. This shifts the approved uses of Xeljanz and Xeljanz XR only to “certain patients who have not responded or cannot tolerate one or more TNF blockers.”

The FDA asks that any adverse events associated with the use of Xeljanz and Xeljanz XR be reported to the MedWatch Voluntary Reporting Program.

You may complete and submit such a report to the MedWatch Program here — or contact us to learn more about your legal options.

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Sokolove Law Team

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Last modified: September 17, 2021

  1. U.S. Food and Drug Administration. “FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions.” 1 Sept. 2021. Retrieved on Sept. 2, 2021 from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death