FDA approves boxed warning for Xeljanz in UC
The FDA on Friday issued a safety alert and approved new Boxed Warning for the 10-mg, twice-daily dosage of tofacitinib in patients with ulcerative colitis; the warning comes after increased blood clot and death risks were seen in a rheumatoid arthritis trial.
Additionally, the FDA alert states that the approved use of tofacitinib (Xeljanz, Pfizer) for UC should be limited to specific patients who are not treated effectively or who experience severe side effects with certain other medicines.
The FDA previously approved tofacitinib for moderate-to-severe UC in 2018.
This new warning approval stemmed from a previous safety alert of Xeljanz for rheumatoid arthritis issued in February, according to the FDA statement.
The FDA has advised that physicians and other health care professions should follow the recommendations in the tofacitinib prescribing information for the specific condition they are treating. Further, providers should monitor patients for signs and symptoms of thrombosis and urge them to seek medical attention immediately if they experience them. Patients who are treated with tofacitinib should immediately seek medical attention if they experience symptoms of a blood clot in their lungs or other symptoms including sudden shortness of breath, chest or back pain, swelling of an arm or leg, as well as red or discolored skin in the painful or swollen arm or leg.
“Reserve tofacitinib to treat ulcerative colitis for patients who have failed or do not tolerate tumor necrosis factor (TNF) blockers,” the FDA said in their statement. “When treating ulcerative colitis, use tofacitinib at the lowest effective dose and limit the use of the 10-mg twice, daily dosage to the shortest duration needed.”