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Increased Risk of Blood Clots and Death with Tofacitinib (Xeljanz, Xeljanz XR)

July 26, 2019

The U.S. Food and Drug Administration has approved a new Boxed Warning 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.

Tofacitinib 10 mg twice daily is not approved or recommended for the treatment of rheumatoid arthritis or psoriatic arthritis.

Report adverse events involving this or other medicines to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).

Instructions for reporting can be found online at the NPTC Pharmacovigilance website.