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# Increased Heart, Cancer Risks with Xeljanz: FDA
- URL: https://www.fdaweb.com/increased-heart-cancer-risks-with-xeljanz-fda/
- Published: 2021-02-04T12:00:00.000Z
- Updated: 2026-09-14T16:45:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148592

FDA says that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with Pfizer’s arthritis and ulcerative colitis drug Xeljanz (tofacitinib) and Xeljanz XR, compared to tumor necrosis factor (TNF) inhibitors. An agency [drug safety communication](https://www.fda.gov/drugs/drug-safety-and-availability/initial-safety-trial-results-find-increased-risk-serious-heart-related-problems-and-cancer-arthritis?utm%5Fmedium=email&utm%5Fsource=govdelivery) says FDA required the safety trial, which also investigated other potential risks, including blood clots in the lungs and death. It says those final results are not yet available.

Xeljanz was first approved in 2012 to treat adults with rheumatoid arthritis (RA) who did not respond well to methotrexate. It was approved in 2017 to treat patients with psoriatic arthritis who did not respond well to methotrexate or similar drugs. And in 2018 Xeljanz was approved to treat ulcerative colitis.

When FDA first approved the drug, it required Pfizer to conduct a safety clinical trial in patients with rheumatoid arthritis who were taking methotrexate to evaluate the risk of serious heart-related events, cancer, and infections.

“The clinical trial is now complete and initial results show a higher occurrence of serious heart-related events and cancer in RA patients treated with both doses of tofacitinib compared to patients treated with a TNF inhibitor,” the communication says. “FDA is awaiting additional results from the trial…. We will evaluate the clinical trial results we have received to date and will work with the drug manufacturer to obtain further information as soon as possible. We will communicate our final conclusions and recommendations when we have completed our review or have more information to share.”