The Food and Drug Administration issued a statement the agency has approved a new Boxed Warning for Xeljanz and Xeljanz XR; as well as approved a warning for the increased risk of blood clots and death for patients with ulcerative colitis.
The new update outlines the medication will be limited to those who have severe side effects with other ulcerative colitis drugs, as well as those who aren’t treated effectively. Doctors are now advised to evaluate patients with symptoms of thrombosis, or blood clots, as well as limiting any 10mg dosages of Xeljanz or Xeljanz XR to the shortest duration possible.
These warnings come from an ongoing clinical safety trial in patients with rheumatoid arthritis, as outlined in the rest of this article.
Xeljanz Overview and Side Effects
Rheumatoid arthritis patients taking a 10mg twice-daily dose of Xeljanz or Xeljanz XR (tofacitinib) have a higher risk of blood clots in the lungs or death, according to results from a postmarketing trial study.
In the postmarketing trial of Xeljanz for those with rheumatoid arthritis, patients were assessed for risk of cardiovascular events, cancer or other opportunistic infections. The Food and Drug Administration approves tofacitinib at 5mg twice a day. The 10mg twice a day study was conducted to evaluate its safety in an elevated dosage.
Pfizer, the trial’s sponsor, was required to conduct the study at the FDA’s request after the agency approved tofacitinib in 2012. This study was to evaluate the safety of Xeljanz at 5mg and 10m dosages, in comparison to a tumor necrosis factor inhibitor (TNFi) control group. Patients were required to be at least 50 years old and have at least one cardiovascular event factor in order to be an eligible participant.
Patients involved in the study were immediately placed back on the 5mg dosage after the safety signal was issued on February 25, 2019.
The Data Safety Monitoring Board first identified the increased risk of mortality in patients, as well as a safety signal for a pulmonary embolism, for those taking the 10mg dosage.
Do not change your tofacitinib unless you have spoken with your doctor. Seek medical attention immediately if any of the following blood clot symptoms while taking tofacitinib:
- Sudden shortness of breath or difficulty breathing
- Chest pain or pain in your back
- Coughing up blood
- Excessive sweating
- Clammy or bluish colored skin
Janet Woodcock, FDA Center for Drug Evaluation and Research Director, said the agency is taking appropriate steps to ensure the safety of those patients who were involved in the study.
“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks.”
Xeljanz was approved in 2012 for treating adults with severe to moderate rheumatoid arthritis, active psoriatic arthritis, and moderate to severe ulcerative colitis. It works by decreasing immune system activity, which is what contributes to RA, psoriatic arthritis (PsA), and ulcerative colitis. It was developed primarily for those who did not respond well to another immune system suppressant, methotrexate.
Patients taking Xeljanz or Xeljanz XR are at risk of developing pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, or appendicitis; all of which could lead to hospitalization or death.