FDA Drug Safety Communication
2-4-2021

The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available.

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.

Patients should not stop taking tofacitinib without first consulting with your health care professionals, as doing so may worsen your condition. Talk to your health care professionals if you have any questions or concerns.
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https://www.fda.gov/drugs/drug-safet...ncer-arthritis