This Xeljanz FDA Drug Safety Communication was issued July 26, 2019: “FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)”.
From that document we get the following information:
The U.S. Food and Drug Administration has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR), which is used in patients with ulcerative colitis. In addition, the approved use of [Xeljanz] for ulcerative colitis will be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines. We approved these changes, including adding our most prominent Boxed Warning, after reviewing interim data from an ongoing safety clinical trial of [Xeljanz] in patients with rheumatoid arthritis (RA) that examined a lower and this higher dose of the medicine.
The 10 mg twice daily dose of [Xeljanz] is not approved for RA or psoriatic arthritis (PsA). This dose is only approved for ulcerative colitis for initial treatment and for long-term use in limited situations. While the increased risks of blood clots and of death were seen in patients taking this dose for RA, these risks may also apply to those taking [Xeljanz] for ulcerative colitis.
Besides this Xeljanz Boxed Warning mandated by FDA in July 2019, two new parts were added to the WARNINGS AND PRECAUTIONS section of the Xeljanz drug label (“Revised: 07/2019” version).
We will continue to monitor developments with respect to the drug safety profile of Xeljanz.
Our law firm is investigating possible Xeljanz lawsuits against the pharmaceutical company Pfizer as personal injury cases or wrongful death claims, depending on the outcome for a patient who suffered Xeljanz side effects.
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