Ulcerative colitis medicine may increase risk of serious heart-related problems, cancer

Preliminary results from a safety clinical trial indicate that tofacitinib may be associated with an increased risk of serious heart-related events and cancer compared to tumor necrosis factor inhibitors.


The FDA recently alerted the public that the arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) was associated with an increased risk of serious heart-related problems and cancer compared to tumor necrosis factor (TNF) inhibitors, according to preliminary results from a safety clinical trial required by the agency. The trial also investigated other potential risks, including blood clots in the lungs and death.

In 2019, the FDA warned that interim trial results showed an increased risk of blood clots and death with the higher 10-mg twice-daily dosage of tofacitinib and, as a result, approved a boxed warning for the prescribing information. Initial results from the clinical trial showed a higher occurrence of serious heart-related events and cancer in patients with rheumatoid arthritis treated with both this higher dose and a lower dose of the drug compared to patients treated with a TNF inhibitor.

The FDA is awaiting additional results from the trial. In the meantime, clinicians should consider the benefits and risks of tofacitinib when deciding whether to prescribe or continue the medication and should continue to follow the recommendations in the drug's prescribing information, the agency said in a Feb. 4 drug safety communication.