FDA drug safety communication on Xeljanz

5 February 2021

The US Food and Drug Administration is again 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.

The 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.

Xeljanz is an important drug for US pharma giant Pfizer (NYSE: PFE), bringing in revenues of $2.44 billion in 2020.

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