February 25, 2019: Increased Risk Of Pulmonary Embolism And Death With Higher Dose Of Tofacitinib (Xeljanz, Xeljanz XR) in Rheumatoid Arthritis Patients

FDA Reports – Increased Risk of Pulmonary Embolism and Death Observed in Tofacitinib Post Marketing Study

On February 25, 2019, the Food and Drug Administration (FDA) announced that data from an ongoing post marketing study found an increased risk of pulmonary embolism (PE) and death in rheumatoid arthritis 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 (RA); however, this dose is approved in the treatment of patients with ulcerative colitis.

Tofacitinib (Xeljanz, Xeljanz XR) Post Marketing Study Requirement

At the time of drug approval, the FDA required manufacturer, Pfizer, to conduct a clinical trial in patients with RA to evaluate the risk of heart-related events, cancer, and opportunistic infections with two different doses of tofacitinib, 10 mg twice daily and 5 mg twice daily, in combination with methotrexate, compared to another drug called a tumor necrosis factor (TNF) inhibitor.

According to the FDA, during a recent trial analysis, an external data safety monitoring committee 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 were on the high dose, 10 mg twice daily, are being transitioned to the lower and currently approved dose of 5 mg twice daily. The clinical trail is 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.

Patients and health care professionals can report Xeljanz side effect and 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 Information

If you or a loved one was injured by a Xeljanz side effect, including pulmonary embolism or a fatality, 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. Please see Xeljanz Lawsuit to learn more about our legal services.


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