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Dangerous Drugs

Xeljanz Linked to Increased Risk of Blood Clots and Death

If you or a loved one have experienced injuries while taking Xeljanz or Xeljanz XR, you may be entitled to significant compensation without ever going to court. Fill out the intake form on this page for a free, no-obligation review of your case and to find out how we might be able to help.

Man grabbing at his heart in pain

FDA issues black box warning for 10 mg dosage

Tofacitinib, more commonly known as Xeljanz or Xeljanz XR, was first approved by the U.S. Food and Drug Administration (FDA) in 2012 and is used to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ulcerative colitis. The drug is available in 5 and 10 mg tablets and works by decreasing the activity of the immune system (an overactive immune system contributes to RA, PsA, and ulcerative colitis).

On July 26, 2019, the FDA approved new warnings for the 10 mg twice daily dose of Xeljanz & Xeljanz XR, the dosage approved to treat ulcerative colitis, over an increased risk of blood clots and death. The warning was added after the FDA reviewed data from an ongoing safety clinical trial of the drug. An analysis of the trial’s results found an increased occurrence of blood clots and death in patients taking the 10 mg twice daily dosage compared to those treated with the 5 mg twice daily dosage or a TNF blocker. The safety trial is ongoing, and the FDA says they will reassess these concerns when it is completed and final, verified data is available.

What you should do if you are currently taking Xeljanz or Xeljanz XR

If you are currently taking Xeljanz or Xeljanz XR, do not stop taking it without first talking to your healthcare professional. Let your health care professional know if you have a history of blood clots or heart problems, or if you have any other questions or concerns. If you are experiencing any unusual symptoms, seek medical attention immediately. Symptoms signaling a blood clot include:

  • Chest pain
  • Sudden shortness of breath
  • Difficulty breathing
  • Coughing up blood
  • Swelling or pain in your leg or arm
  • Red or discolored skin
  • Lower leg cramp

Find out if you could qualify for compensation

If you or a loved one have experienced injuries while taking Xeljanz or Xeljanz XR, we’re here to help. You may be entitled to significant compensation without ever going to court. Fill out the intake form on this page for a free, no-obligation review of your case.