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The Food and Drug Administration (FDA) has approved changes to the prescribing information for tofacitinib to include new warnings, including a Boxed Warning, regarding an increased risk of blood clots and death associated with the 10mg twice daily regimen.  The update comes after a review of data from an ongoing safety clinical trial of tofacitinib…

The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.

According to data from on an ongoing postmarketing safety trial conducted by Pfizer, tofacitinib dosed at 10mg twice daily was associated with an increased risk of pulmonary embolism and overall mortality in patients with rheumatoid arthritis (RA).

The FDA has approved Xeljanz XR (tofacitinib extended-release; Pfizer) for the treatment of adult patients with moderately to severely active ulcerative colitis.

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for upadacitinib (AbbVie), an investigational oral JAK1-selective inhibitor, for the treatment of moderate to severe rheumatoid arthritis (RA).