FDA Mulls New Xeljanz Restrictions After Study Raises Heart and Cancer Concerns

Published on February 19, 2021 by Laurie Villanueva

Federal drug regulators are considering further restrictions on Xeljanz after initial results from a new study linked the arthritis and ulcerative colitis medication to a higher risk of serious heart problems and cancer compared to Humira and other TNF inhibitors.

“We will evaluate the clinical trial results we have received to date and will work with the drug manufacturer to obtain further information as soon as possible,” the U.S. Food & Drug Administration (FDA) said in a communication issued on February 4^th. “We will communicate our final conclusions and recommendations when we have completed our review or have more information to share.”

FDA First Approved Xeljanz in 2012

Xeljanz was first approved in 2012 to treat adults with rheumatoid arthritis who did not respond well to methotrexate. Five years later, the drug was approved to treat patients with psoriatic arthritis who did not respond well to methotrexate or other similar medicines. In 2018, the FDA approved Xeljanz to treat ulcerative colitis, a chronic, inflammatory disease affecting the colon.

Xeljanz belongs to a class of drugs called JAK inhibitors that work by suppressing the immune system. An overactive immune system is known to contribute to these three indications. Xeljanz is an oral medication available in either a 5mg twice-daily dose or a 10-mg twice-daily dose. Xeljanz XR is an 11mg extended-release tablet.

Xeljanz Black Box Warning for Blood Clots

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. Interim 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.

Those findings prompted the FDA to order a new Black Box Warning – its strongest safety notice – to be added to the Xeljanz label.  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.  Doctors are now cautioned to prescribe the lowest effective dose possible and limit the 10mg twice-daily regimen to the shortest duration possible.

Cancer, Heart Problem Risks Seen with Both Xeljanz Doses

That trial is now complete. According to the FDA, the initial results show a higher occurrence of serious heart-related events and cancer in rheumatoid arthritis patients treated with both the 5mg and 10mg doses of Xeljanz than patients treated with a TNF inhibitor. The agency is now awaiting additional results from the trial.

For now, patients should NOT stop taking Xeljanz without first consulting with their health care professionals, as doing so may worsen their condition. Health care professionals should consider the benefits and risks of Xeljanz when deciding whether to prescribe or continue patients on the medicine.