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On February 25, 2019, the FDA issued a warning that tofacitinib (Xeljanz, Xeljanz XR) may increase the risk of pulmonary embolism in patients with rheumatoid arthritis. This alert is based on an ongoing safety clinical trial in patients greater than 50 years of age with rheumatoid arthritis and at least one cardiovascular risk factor. Patients were randomized to receive methotrexate plus tofacitinib 10 mg twice daily, methotrexate plus tofacitinib 5 mg twice daily, or a tumor necrosis factor inhibitor agent as monotherapy. The external data safety monitoring committee in this study noticed a higher incident of pulmonary embolism and death in the treatment group receiving tofacitinib 10 mg twice daily plus methotrexate compared with the other two intervention groups.
The FDA recommends health care professionals to follow tofacitinib dosing recommendations within the prescribing information since the risk was associated with a dose higher than what is recommended. Patients should not discontinue tofacitinib without consulting their healthcare professionals. Patients are advised to monitor for signs and symptoms of pulmonary embolism such as chest pain, coughing up blood, or sudden shorten of breath and seek immediate attention if these symptoms are present. Prescribers are urged to report side effects involving tofacitinib through the FDA MedWatch Program: www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
More information is available at the following links:
- FDA Safety Alert
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm632016.htm - FDA Safety Announcement
www.fda.gov/Drugs/DrugSafety/ucm631871.htm