European Regulator Issues Xeljanz Warning After Study Sees Pulmonary Embolism, Death Risk with Higher Dose

Published on March 26, 2019 by Laurie Villanueva

Regulators in Europe have issued a new Xeljanz warning, after data from an ongoing study suggested pulmonary embolism and death occurred more frequently among patients taking a higher dose of the medication.

What is Xeljanz?

Xeljanz is a twice-daily tablet indicated to treat adults with RA, psoriatic arthritis, or ulcerative colitis.

The drug is available in two doses, 5mg and 10mg. But the U.S. Food & Drug Administration (FDA) has only approved the higher dose of Xeljanz for ulcerative colitis, while the European Medicines Agency (EMA) recommends the 10mg twice-daily regimen for both ulcerative colitis and psoriatic arthritis.

The FDA initially cleared Xeljanz for RA in 2012. However, the agency also ordered Pfizer, Inc. to conduct several post-market studies to assess the risks of heart-related events, cancer, and opportunistic infection associated with two Xeljanz dosing regimens (5 mg twice daily and 10 mg twice daily) in comparison with another class of RA medications calls tumor necrosis factor (TNF) inhibitors.

What the Xeljanz Study Found

The FDA issued a Xeljanz warning late last month, after data from one of these post-market studies  (A3921133) showed an increased risk of blood clots in the lungs (pulmonary embolism) and death among Xeljanz patients taking the 10mg dose.

Pfizer designed A3921133 to evaluate the risk of heart and circulatory problems among Xeljanz patients 50 years of age or older who already faced a higher risk of these events. Because of the early findings, the company transitioned all patients in the study’s 10mg Xeljanz group to the lower-dose arm.

“This trial will continue and is expected to be completed by the end of 2019. We are working with the manufacturer to evaluate other currently available safety information for tofacitinib and will update the public with any new information based on our ongoing review,” the FDA said in Drug Safety Communication dated February 25th.

What the EMA Xeljanz Warning Says

The EMA published its own Xeljanz warning on March 20th.

Among other things, the regulator cautioned doctors not to exceed the 5mg dose when treating RA, and to monitor all Xeljanz patients for signs of pulmonary embolism.

The EMA also advised patients:

  • That the 10 mg Xeljanz dose is higher than the approved dose for RA
  • Not to change their dose or stop taking Xeljanz without discussing it with their doctor.
  • To seek medical attention immediately for any signs of a pulmonary embolism, including difficulty breathing, chest pain or pain in your upper back, coughing up blood, excessive sweating and bluish skin.
  • To discuss any Xeljanz concerns with their healthcare professional.

The EMA’s statements echoed the earlier Xeljanz warning published in the United States. At that time, the FDA also urged doctors and patients to report any possible Xeljanz side effects to the MedWatch Safety Information and Adverse Event Reporting Program, either by completing an online form  or by calling 1-800-332-1088.

The FDA is working with Pfizer to evaluate all currently available Xeljanz safety, and will update the public with any new information obtained in the course of its ongoing review.

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