Patients with rheumatoid arthritis (RA) treated with 10mg twice daily doses of Xeljanz or Xeljanz XR (tofacitinib), were at an increased risk of blood clots in the lungs (pulmonary embolism) and death, according to a safety clinical trial. The Food and Drug Administration (FDA) has not approved this dosage of Xeljanz RA for patients with RA; only for patients with ulcerative colitis.
This issue was discovered during a clinical trial Pfizer was required to conduct when the drug was first approved by the FDA in 2016. The trial was designed to evaluate the risk of heart-related events, cancer and infection with twice daily 10mg doses or 5 mg twice daily doses in combination with methotrexate compared with another drug called a tumor necrosis factor (TNF) inhibitor. RA patients enrolled in the trial were required to be at least 50 years old and have at least one cardiovascular risk factor.
During the most recent analysis of that trial, an external data safety monitoring committee found that patients treated with 10mg twice-daily doses of Xeljanz compared to patients treated with 5mg twice-daily doses of Xeljanz or a TNF inhibitor were more likely to experience a pulmonary embolism or die.
The FDA advised health care providers follow the recommended prescribing information for Xeljanz and monitor patients for signs and symptoms of pulmonary embolism. Patients taking Xeljanz should also seek immediate medical attention if they experience any signs of a blood clot in the lungs such as sudden shortness of breath or difficulty breathing, chest pain or pain in the back, coughing up blood, excessive sweating, or clammy or bluish colored skin.
Any adverse events in patients treated with Xeljanz should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Safety Alert