Skip to main content
main-content
Top

02-09-2021 | JAK inhibitors | News

Regulatory update

FDA requires boxed warning updates for JAK inhibitors

Author: Claire Barnard

share
SHARE
print
PRINT
insite
SEARCH

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

share
SHARE
print
PRINT

New additions to the Adis Journal Club

A monthly selection of topical peer-reviewed articles from the Adis journals, curated by the editors.

Rituximab and rheumatology practice in the COVID-19 era

How can rheumatologists respond to the challenges associated with rituximab use during the pandemic?

Related content

11-08-2021 | JAK inhibitors | Feature | Article

JAK inhibitor safety: Distilling the evidence

Peter Nash discusses the latest evidence on the association between JAK inhibitors and the risk for VTE, MACE, and malignancy