A New FDA Warning for Tofacitinib

2/4/21: FDA: Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)

“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….

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.”

Related blog post: FDA Warning on Tofacitinib (July 2019)

3 thoughts on “A New FDA Warning for Tofacitinib

  1. Pingback: What Can We Conclude from Five Patients Treated with a Combination of Infliximab and Tofacitinib? | gutsandgrowth

  2. Pingback: FDA Slaps Restrictions on JAK Inhibitors Over Serious Safety Risks | gutsandgrowth

  3. Pingback: IBD Shorts: Tofacitinib Safety, Vit D post-op, EIM with Vedolizumab | gutsandgrowth

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