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.
Ulcerative colitis (UC) is a chronic inflammatory bowel disease, characterized by recurring flares of abdominal pain and bloody diarrhea. Symptoms also may include fatigue, weight loss and fever.
Some 900,000 people in the United States have UC, for which there is no cure, the FDA said in a news release.
Xeljanz was first approved in 2012 for rheumatoid arthritis, and in 2017 for psoriatic arthritis.
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.
Learn more from the FDA.
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