New Boxed Warning Added to Xeljanz

In early 2019, the U.S. Food and Drug Administration (FDA) announced that a 10 mg twice-daily dose of Xeljanz put patients at a higher risk of developing blood clots in their lungs and death. The FDA reached that conclusion after reviewing data compiled by an external safety monitoring committee that observed the results of a clinical trial conducted by the drug’s manufacturer, Pfizer.

In July 2019, the FDA required that the drug’s manufacturer add a Boxed Warning to the medication. A Boxed Warning is the agency’s most prominent warning and is designed to call attention to serious or life-threatening risks associated with a drug. In addition, the FDA also restricted the usage of Xeljanz to only certain health problems due to its risks of causing patients to develop potentially fatal blood clots.

If you or someone you love was prescribed Xeljanz, it’s important to be aware of your risks and watch for the following symptoms:

  • 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

Don’t stop taking Xeljanz without first speaking to your doctor about your risks. However, if you notice any of the side effects listed above, seek medical attention right away, as it could be a sign of a dangerous health complication.

The drug injury lawyers at Ferrer, Poirot & Wansbrough are here to help anyone who was injured by Xeljanz and other medications that were supposed to treat their illnesses. Contact us today for a free consultation.