Tofacitinib under the spotlight after FDA warning

Data from the US raises concerns for people with ulcerative colitis taking high doses of JAK inhibitor tofacitinib, which is also approved for rheumatoid arthritis.

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

The agency says tofacitinib for ulcerative colitis should be limited to people who have not responded to other treatments or who experience severe side effects with certain other medicines.

Earlier this year, the FDA raised a similar alert for the use of the drug in rheumatoid arthritis.

People who are treated with tofacitinib should seek medical attention if they experience symptoms of a blood clot in their lungs, sudden shortness of breath, chest or back pain, swelling of an arm or leg, or discoloured skin in a painful or swollen arm or leg.

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