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05-03-2019 | Rheumatoid arthritis | News

Regulatory update

FDA issues tofacitinib safety alert


medwireNews: The US FDA warns that treatment with the Janus kinase inhibitor tofacitinib at a dose of 10 mg twice daily is associated with an increased risk for pulmonary embolism and death in patients with rheumatoid arthritis (RA).

This announcement is based on the results of an ongoing safety trial that is expected to be completed by the end of 2019.

The 10 mg twice daily dose of tofacitinib, used for the treatment of ulcerative colitis, is not currently approved for RA, says the FDA, noting that the drug manufacturer Pfizer is switching RA patients treated with the higher dose of tofacitinib to the currently approved dose of 5 mg twice daily.

The warning specifies that healthcare professionals should monitor tofacitinib-treated patients for signs of pulmonary embolism and follow prescribing information for the condition they are treating.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group