Increased Death and PE Risk Observed in Xeljanz (tofacitinib) Post Marketing Study
Xeljanz Side Effects – The US Food and Drug Administration (FDA) announced on February 25, 2019, that data from an ongoing post marketing study has demonstrated an increased risk of pulmonary embolism (PE) and death in rheumatoid arthritis (RA) patients treated with a 10 mg twice daily dose of tofacitinib (marketed as Xeljanz, Xeljanz XR). The FDA has not approved the 10 mg twice daily dose of tofacitinib for rheumatoid arthritis; however, this dose is approved in the treatment of ulcerative colitis.
Tofacitinib (Xeljanz, Xeljanz XR) Post Marketing Study Requirement
At the time of marketing approval, the FDA required Xeljanz manufacturer, Pfizer, to conduct a post marketing study in patients with RA to evaluate the risk of cardiovascular events, cancer, and opportunistic infections. The study followed patients taking two different Xeljanz doses, 10 mg twice daily and 5 mg twice daily, in combination with methotrexate, compared to patients taking another drug called a tumor necrosis factor (TNF) inhibitor.
During a recent trial analysis, the study’s external Data Safety Monitoring Board found an increased occurrence of pulmonary embolism (blood clots in the lungs) and death in patients treated with tofacitinib 10 mg twice daily when compared to patients treated with tofacitinib 5 mg twice daily or a TNF inhibitor. Study patients who received the high dose, 10 mg twice daily, are being transitioned to the lower and currently approved tofacitinib dose of 5 mg twice daily. The study is ongoing, and expected to be completed by the end of 2019. The FDA reports that it will work with Pfizer to evaluate available safety information and that the public will be updated based on the ongoing review.
Health care professionals and patients can report Xeljanz side effects and other medication side effects to the FDA MedWatch program at MedWatch.
FDA Information for Health Care Professionals
Health care professionals are advised to follow the recommendations in the tofacitinib prescribing information for the specific condition being treated. Patients should be monitored for the signs and symptoms of pulmonary embolism, and advised to seek medical attention immediately if they experience these signs and/or symptoms.
FDA Information for Patients
The FDA cautioned patients as follows:
“Patients should not stop or change your dose of tofacitinib without first talking to your health care professional, as doing so may worsen your condition. Patients taking tofacitinib should seek medical attention immediately if you experience symptoms of a blood clot in your lungs or other unusual symptoms such as:
• Sudden shortness of breath or difficulty breathing
• Chest pain or pain in your back
• Coughing up blood
• Excessive sweating
• Clammy or bluish colored skin”
Xeljanz Lawsuit Help
If you or a loved one was injured by a Xeljanz side effect, and you would like more information regarding your legal rights, please call our firm toll free at 877-934-6274 for a free legal case evaluation.
