UNITED STATES – The U.S. Food and Drug Administration has approved a Black Box warning for the Xeljanz (tofacitinib) drug label due to a higher risk of blood clots and death. The changes followed a review of data from a clinical trial on the safety of Xeljanz and Xeljanz XR in patients with rheumatoid arthritis taking a higher dose of the drug each day.
Xeljanz is approved for treatment of several conditions, including rheumatoid arthritis and ulcerative colitis. The drug was initially approved for rheumatoid arthritis in 2012 at doses of 5 mg twice per day. The drug’s use was expanded to psoriatic arthritis in 2017 and to ulcerative colitis in 2018. Patients taking Xeljanz for ulcerative colitis can have doses of 10 mg twice per day.
The FDA has required post market studies on the drug to continue to monitor its safety and efficacy, and in an ongoing trial, patients with rheumatoid arthritis were taking the higher dose of Xeljanz — 10 mg twice per day. These patients were found to have an increased risk of developing blood clots and of dying than patients who took a different medication or patients who took a lower dose of Xeljanz.
In response to these findings, the FDA ordered a boxed warning, which is the strongest type of warning for a drug, to accompany the drug label concerning doses of 10 mg twice a day. The FDA further ordered that the warning state that patients with ulcerative colitis should only take Xeljanz if they have not responded to treatment with other medications or have experienced side effects to those medications.
The FDA advised patients taking Xeljanz or patients who might be candidates for Xeljanz to tell their doctors about any past issues with blood clots or heart issues and to immediately seek medical treatment if they have symptoms of a blood clot.
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation
Have you or a loved one been harmed by Xeljanz?Click To Get A Free Case Review