FDA Approves New Black Box Warning for Xeljanz and Xeljanz XR Communicating Risk of Blood Clots and Death
Xeljanz and Xeljanz XR are Janus Kinase Inhibitors (JAKs) and are part of the class of drugs called “disease-modifying antirheumatic drugs (DMARDs).” Xeljanz and Xeljanz XR are used to treat a variety of medical conditions, including ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis. Dosing for Xeljanz and Xeljanz XR may be different depending on what condition a patient has been diagnosed with, and the drugs have been approved for use by the FDA is various doses for each of the applicable medical conditions.
Drug Trial Uncovers Risk of Blood Clots and Death
An ongoing post-market drug trial that has investigated the use of Xeljanz and Xeljanz XR in patients with rheumatoid arthritis reveals that patients may be at risk of suffering blood clots or death when given 10mg twice daily. The United States Food and Drug Administration (FDA) has only approved a 10mg twice daily dosage for the treatment of ulcerative colitis. Additionally, using Xeljanz or Xeljanz XR is only approved for use in patients who have not responded to other forms of treatment and/or had side effects with other forms of treatment.
The New Xeljanz/Xeljanz XR Black Box Warning
A black box warning is the most serious category of warning available for prescription drugs, and such a warning is required when a prescription drug has the potential to cause serious injury/illness or death. Because the drug trial results indicated that the use of Xeljanz at a dose of 10mg twice daily for the treatment of rheumatoid arthritis increases the risk of blood clots and death, the FDA is requiring a stronger warning to ensure healthcare providers and patients are aware of the serious risks associated with taking Xeljanz or Xeljanz XR.
The FDA has approved a new label for Xeljanz and Xeljanz XR that identifies the newly discovered risks resulting from the ongoing post market study. The stronger warning required by the FDA is identified in a “black box,” which is a warning that literally has a black box around it. The black box warning for Xeljanz and Xeljanz XR appears at the top of the drug labels, providing a long list of risks associated with taking the drugs. The black box warning covers slightly more than one page. The following new language now appears in the black box warning contained in the Xeljanz and Xeljanz XR drug labels:
- “MORTALITY – Rheumatoid arthritis patients 50 years of age and older with at least one cardiovascular (CV) risk factor treated with Xeljanz 10mg twice a day had a higher rate of all-cause mortality, including sudden CV death, compared to those treated with Xeljanz 5mg given twice daily or TNF blockers.”
- “THROMBOSIS – Thrombosis, including pulmonary embolism, deep vein thrombosis, and arterial thrombosis, has been observed at an increased incidence in rheumatoid arthritis patients who were 50 years of age or older with at least one CV risk factor treated with Xeljanz 10mg twice a day compared to Xeljanz 5 mg twice daily or TNF blockers.”
- “For patients with ulcerative colitis, use Xeljanz at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.”
Following approval of a new black box warning, the FDA is recommending that Xeljanz and Xeljanz XR be avoided in patients who have a higher risk of thrombosis (blood clots). Overall, the ongoing post-market study demonstrates that Xeljanz and Xeljanz XR should be used sparingly in very limited circumstances and that the risks associated with taking the drug to treat ulcerative colitis, rheumatoid arthritis or psoriatic arthritis are substantial compared to the potential benefits.
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