WEDNESDAY, May 30, 2018 (HealthDay News) -- U.S. Food and Drug Administration approval of Xeljanz (tofacitinib) has been expanded to include adults with active moderate-to-severe ulcerative colitis, the agency said Wednesday.
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Some 900,000 people in the United States have UC, for which there is no cure, the FDA said in a news release.
In clinical studies evaluating the pill's use for UC, the most common side effects were diarrhea, high cholesterol, headache, herpes zoster (shingles) infection, cold-like symptoms, rash and upper respiratory infection.
The drug's label includes the agency's most serious "boxed warning" of less common adverse reactions including serious infections and cancer, the FDA said.
The agency warned against using Xeljanz in tandem with biological therapies for UC, or with potent medications that suppress the body's immune system.
Xeljanz is produced by New York City-based Pfizer.
-- Scott Roberts
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