FDA issues new warning on Pfizer’s Xeljanz

February 9, 2021
Christine Blank

Preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the rheumatoid arthritis and ulcerative colitis medicine Xeljanz.

The FDA is warning about an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine tofacitinib (Xeljanz and Xeljanz XR, Pfizer).

FDA added a Boxed Warning to Xeljanz and Xeljanz XR in 2019 after the agency found that interim trial results showed an increased risk of blood clots and death with the higher dosage of 10 milligrams, twice a day.

Related: FDA adds warning to Xeljanz

At the time, the agency ordered safety clinic trials, which also investigated other potential risks including blood clots in the lungs and death.

The initial results of one of the trials shows a higher occurrence of serious heart-related events and cancer in RA patients compared with those treated with a TNF inhibitor, leading to the new warning, FDA said in a press release.

Related: Rheumatoid arthritis drug poses fatal side effect

FDA is awaiting additional results from the trial.

Patients should not stop taking tofacitinib without first consulting with their healthcare professionals, while healthcare professionals should consider the benefits and risks of tofacitinib when deciding whether to prescribe or continue patients on the medicine.

The FDA is also encouraging healthcare professionals and patients to report adverse events or side effects related to the use of tofacitinib to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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