European Regulator Investigating Xeljanz Pulmonary Embolism Risk

Published on March 19, 2019 by Laurie Villanueva

Regulators in Europe have launched a safety review of Xeljanz, amid concern that patients might be more likely to suffer a pulmonary embolism or die while taking a higher dose of the medication.

The European Xeljanz review was announced on March 1st, just days after regulators in the United States announced a similar evaluation.

Xeljanz Pulmonary Embolism Risk in Post-Market Trial

Pfizer’s Xeljanz is currently indicated to treat adults suffering from rheumatoid arthritis (RA), psoriatic arthritis, and ulcerative colitis.

The medication is sold in 5mg and 10mg doses. However, the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) have only cleared the  higher-dose version of Xeljanz for ulcerative colitis.

The EMA initially refused to approve Xeljanz in 2013, citing concern over side effects that included serious infections, increased cholesterol, and heightened cardiovascular risks.

The FDA reviewed the same data when it approved Xeljanz for RA the previous year. However, the agency also asked Pfizer to conduct the post-market clinical trial that turned up the most recent safety signals.

According to the agency’s February 25th Drug Safety Communication, patients currently enrolled in the study’s 10mg Xeljanz arm are being transitioned to the 5mg group.

“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 agency said.

What Should Xeljanz Patients Do?

A pulmonary embolism is a dangerous blood clot that occurs in the lungs.

Because these blood clots are often deadly, patients should seek medical attention if they experience any symptoms that might indicate a Xeljanz pulmonary embolism, including:

  • Sudden shortness of breath or difficulty breathing
  • Chest pain or pain in your back
  • Coughing up blood
  • Excessive sweating
  • Clammy or bluish colored skin

According to the FDA, patients concerned about these potential risks should not stop taking Xeljanz or change their dose without first talking to their doctor, as this could worsen their condition.

Healthcare professionals and patients may report suspected Xeljanz side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, either by completing an online form  or by calling 1-800-332-1088.

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