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29-07-2019 | Rheumatoid arthritis | News

Regulatory update

FDA adds boxed warnings to tofacitinib label

medwireNews: The US FDA has approved new warnings concerning the risk for pulmonary embolism and death among patients treated with the Janus kinase (JAK) inhibitor tofacitinib at a dose of 10 mg twice daily.

This announcement follows an earlier alert warning of these increased risks earlier in 2019.

The approved changes to the label include “adding our most prominent Boxed Warning, after reviewing interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis (RA) that examined a lower and this higher dose of the medicine,” says the FDA in a safety announcement.

The 10 mg twice daily dose of tofacitinib is not approved for RA or psoriatic arthritis, but is currently used to treat ulcerative colitis.

Interim findings from the ongoing safety trial identified 19 cases of pulmonary embolism during 3884 person–years of follow-up among patients who received tofacitinib 10 mg twice daily, compared with three cases during 3982 person–years among those receiving tumor necrosis factor (TNF) inhibitors. A total of 45 patients treated with the higher dose of tofacitinib and 25 given TNF inhibitors died.

Noting that it will “reassess these safety issues when the trial has completed and final, verified data are available,” the FDA advises that patients with symptoms of thrombosis should discontinue tofacitinib, and that the JAK inhibitor should not be given to those with elevated risk for thrombosis.

By Claire Barnard

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

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