Despite Xeljanz Blood Clot Risk, FDA Clears Extended Release Version for Ulcerative Colitis

Published on December 20, 2019 by Sandy Liebhard

The U.S. Food & Drug Administration (FDA) has approved Xeljanz XR to treat adults with moderate-to-severe active ulcerative colitis.

According to a Pfizer, Inc. press release, the higher dose, extended release versions of Xeljanz are only indicated for ulcerative colitis patients who have had inadequate response or are intolerant to another medication class called tumor necrosis factor (TNF) blockers.

Xeljanz Approval History

The FDA approved Xeljanz (5 mg twice daily) to treat rheumatoid arthritis in 2012. Four years later, Pfizer received the agency’s approval to market Xeljanz XR (11mg) for the same indication. Both Xeljanz versions were approved to treat adults with psoriatic arthritis in 2017, while the 10 mg twice-daily Xeljanz regimen was approved to treat ulcerative colitis in 2018.

When the FDA initially approved Xeljanz, Pfizer was ordered to conduct a post-market study comparing the rate of certain heart-related complications among rheumatoid arthritis patients receiving either the 5mg twice-daily dose, the 10-mg twice daily regimen, or TNF blockers.

Preliminary results from that study suggested patients taking the higher dose of Xeljanz were more likely to experience a pulmonary embolism – a life-threatening blood clot that travels to the lungs — or die compared to those taking either the lower dose or a TNF blocker.

FDA Xeljanz Blood Clot Warning

The Xeljanz blood clot findings prompted the FDA to launch a new safety review last February. By that point,  Pfizer had already begun to transition all participants in the study’s high-dose Xeljanz arm to the 5mg twice-daily regimen.

In July, the FDA ordered Pfizer to update the Xeljanz Black Box Warning to note the potential for pulmonary embolism. The agency also limited the approved use of Xeljanz for ulcerative colitis to patients who are not treated effectively or who experience severe side effects with certain other medicines.  In such cases, doctors should prescribe the lowest effective dose possible and limit the 10mg twice-daily regimen to the shortest duration possible.

Patients taking Xeljanz should seek emergency medical attention if they experience any symptoms of pulmonary embolism or other blood clots, including:

• Sudden shortness of breath
• Chest pain that worsens with breathing
• Swelling of a leg or arm
• Leg pain or tenderness, or red or discolored skin in the painful or swollen leg or arm

The FDA recommends that doctors avoid prescribing Xeljanz to patients already at high risk for blood clots. Current Xeljanz patients should let their doctor know if they have a history of blood clots, including pulmonary embolism and deep vein thrombosis. However, they should not stop taking the medication without first consulting their healthcare provider, as doing so could significantly worsen their condition.