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02-09-2021 | JAK inhibitors | News

Regulatory update

FDA requires boxed warning updates for JAK inhibitors

Author: Claire Barnard


medwireNews: The US FDA has issued an updated safety communication announcing that boxed warnings on the labels for tofacitinib, baricitinib, and upadacitinib must be updated to include information on the risk for serious cardiovascular (CV) events, cancer, blood clots, and death.

In addition, use of Janus kinase (JAK) inhibitors in the USA will be limited to certain patients with an inadequate response or intolerance to tumor necrosis factor (TNF) inhibitors.

This announcement is based on a completed FDA review of the ORAL Surveillance safety trial, which found an increased risk for serious CV events such myocardial infarction or stroke, as well as cancer, blood clots, and death among people with rheumatoid arthritis taking tofacitinib versus TNF inhibitors. In contrast to a previous safety communication reporting an elevated risk for blood clots and death only with the higher 10 mg twice-daily dose of tofacitinib, the final analysis also found an increased risk for these events with the lower 5 mg twice-daily dose.

While baricitinib and upadacitinib have not been studied in large safety trials, the FDA says that “these medicines may have similar risks as seen in the [tofacitinib] safety trial” given their similar mechanisms of action, and therefore requires the boxed warning updates for all three JAK inhibitors.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group


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