The U.S. Food and Drug Administration has put patients and medical professionals on notice.  A required rheumatoid arthritis (RA) safety clinical trial reveals that Pfizer’s tofacitinib (Xeljanz, Xeljanz XR) increases the risk of blood clots in the lungs and death when a 10 mg twice daily dose was used in participating patients. The FDA has not approved this 10 mg twice daily dose for RA. This dose level is only approved for patients with ulcerative colitis.

Consequently, Pfizer is transitioning patients who were on the high 10 mg twice daily dose to the lower, currently approved dose of 5 mg twice daily.  The trial will continue and is expected to be completed by the end of 2019. 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

Tofacitinib works by decreasing the activity of the immune system. It was first approved in 2012 to treat adult patients with RA who did not respond well to the medicine methotrexate. In RA, the body attacks its own joints, causing pain, swelling, and loss of function. In 2017, we approved the medicine to treat patients with a second condition, psoriatic arthritis, who did not respond well to methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs). Psoriatic arthritis is a condition that also causes joint pain and swelling. In 2018, we approved tofacitinib to treat a condition called ulcerative colitis, which is a chronic, inflammatory bowel disease affecting the colon.

When FDA first approved tofacitinib, we required a clinical trial among patients with RA to evaluate the risk of heart-related events, cancer, and opportunistic infections with the medicine at two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate in comparison to another drug called a tumor necrosis factor (TNF) inhibitor. RA patients 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 the trial, an external data safety monitoring committee found an increased occurrence of blood clots in the lungs and death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF inhibitor.

To help FDA track safety issues with medicines, we urge health care professionals and patients to report side effects involving tofacitinib or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

Source: FDA

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