EMA warns on risk of blood clots and death with higher dose of Xeljanz for RA

22 March 2019

The European Medicines Agency is advising healthcare professionals and patients not to exceed the recommended dose of Pfizer’s (NYSE: PFE) Xeljanz (tofacitinib) when treating rheumatoid arthritis (RA).

The advice follows early results from an ongoing study (study A3921133) in patients with rheumatoid arthritis which showed an increased risk of blood clots in the lungs and death when the normal dose of 5mg twice daily was doubled.

In the European Union, 5mg twice daily is the authorized dose for rheumatoid arthritis and psoriatic arthritis. The higher dose of 10mg twice daily is approved for the initial treatment of patients with ulcerative colitis.

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