The FDA issued a safety alert Feb. 4 saying that tofacitinib may increase patients' risk for cancer and heart-related problems, according to preliminary results from a safety clinical trial.
The drug, produced by Pfizer and sold under the brand name Xeljanz, treats arthritis and ulcerative colitis.
The alert is based on data from a post-marketing clinical trial required by the FDA to investigate the drug's risks compared to other TNF inhibitors. Early data showed that tofacitinib was associated with a higher rate of major adverse cardiovascular events and malignancies than other TNF inhibitors. The study focused on patients ages 50 years and older who have underlying cardiovascular risk factors.
The FDA recommended healthcare professionals weigh the benefits and risks of the drug when prescribing it to patients. The agency also discouraged patients who are prescribed the drug from discontinuing use without first consulting their physician, as doing so could worsen their condition.
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