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  5. FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)
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FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)

FDA Drug Safety Podcast

FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin Advanced Practice Nurse.

On July 26, 2019, FDA approved new warnings about an increased risk of blood clots and death with the 10 mg twice daily dose of tofacitinib (brand names Xeljanz, Xeljanz XR), used in patients with ulcerative colitis. The approved use of tofacitinib for ulcerative colitis will also be limited to patients who are not treated effectively or who experience severe side effects with certain other medicines. We approved these changes, adding our most prominent Boxed Warning, after reviewing interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis (RA) that examined a lower and this higher dose of the medicine.

The 10 mg twice daily dose of tofacitinib is only approved for initial treatment of ulcerative colitis and for long-term use in limited situations. While the increased risks of blood clots and death were seen in patients taking this dose for RA, these risks may also apply to those taking tofacitinib for ulcerative colitis.

Tofacitinib was approved in 2012 to treat adult patients with RA who did not respond well to methotrexate. In 2017, we approved Tofacitinib to treat patients with psoriatic arthritis, who did not respond well to other medicines and in 2018, to treat ulcerative colitis.

Health care professionals should discontinue tofacitinib and evaluate patients with symptoms of thrombosis. Tofacitinib should be reserved to treat ulcerative colitis in patients who have failed or do not tolerate tumor necrosis factor (TNF) blockers. Avoid tofacitinib in patients who may have a higher risk of thrombosis, use tofacitinib at the lowest effective dose and limit use of the 10 mg twice daily dosage to the shortest duration needed.

When FDA first approved tofacitinib, we required a postmarketing clinical trial in patients with RA on methotrexate, to evaluate the risk of heart-related events, cancer, and infections. An interim analysis of the trial’s results found an increased occurrence of blood clots and death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF blocker. FDA will reassess these safety issues when the trial has completed.

Side effects involving tofacitinib should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the interim trial results can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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