FDA Issues Safety Alert for Xeljanz and Xeljanz XR
February 25, 2019 – The U.S. FDA has issued a safety communication for both Xeljanz® (tofacitinib) and its extended release formulation, Xeljanz XR®, following the results of a safety clinical trial. During the trial, the products’ active ingredient, tofacitinib, was found to increase the risk of blood clots in the lungs and death when patients who had rheumatoid arthritis (RA) used a 10mg twice-daily dose.
The safety trial was required as a condition of the FDA’s initial approval of tofacitinib to evaluate the risk of heart-related events, cancer, and opportunistic infections when used at either a 5mg or 10mg twice-daily dose in combination with methotrexate. Patients who participated in the trial were at least 50 years of age and had an RA diagnosis plus at least one cardiovascular risk factor.
Currently, the 10mg twice-daily dosage of Xeljanz and Xeljanz XR is only FDA approved to treat patients who have ulcerative colitis. The FDA asks prescribers to follow the recommendations found in the products’ prescribing information for the specific condition being treated. Patients should be monitored for signs of pulmonary embolism (blood clots in the lungs) and advised to seek medical attention immediately if they experience symptoms.
Adverse events that may be related to the use of Xeljanz or Xeljanz XR should be reported to the patient’s healthcare provider, and can also be submitted to the FDA’s MedWatch program.