The U.S. Food and Drug Administration (FDA) has issued a Safety Announcement after a safety clinical trial of the immunology drug tofacitinib found an increased risk of pulmonary embolism and death in patients on a twice-daily 10-mg dose for the treatment of rheumatoid arthritis (RA).
The ongoing trial, which enrolled patients with RA who were at least 50 years old and had at least one cardiovascular risk factor, was intended to compare the risks of heart-related events, cancer, and opportunistic infections associated with tofacitinib at two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate with the safety profile of a tumor necrosis factor inhibitor.
Drug maker Pfizer, which markets tofacitinib as Xeljanz and Xeljanz XR, is transitioning patients on the trial to the lower, currently approved dose of 5 mg twice daily. The higher 10 mg dose was approved for patients with ulcerative colitis in 2018, but not for patients with RA.
“… The FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement.