The FDA on Friday issued a safety alert and approved new warnings for the 10-mg, twice-daily dosage of tofacitinib after a possible increased risk for pulmonary embolism and mortality in patients with ulcerative colitis.
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

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