Navigating JAK Inhibitor Warnings

Janus kinase (JAK) inhibitors help ease joint pain and swelling in patients with rheumatoid arthritis (RA) by tamping down an overactive immune system to help prevent damage to joints.

The FDA recently recommended that healthcare professionals consider the benefits and risks for the individual patient prior to initiating or continuing therapy with a number of specified JAK inhibitors and required revisions to the Boxed Warning for these drugs to include information about the risks of serious heart-related events, cancer, blood clots and death.

Furthermore, the FDA will limit approved uses for these drugs to certain patients who have not responded to or cannot tolerate one or more TNF blockers, which suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune-system diseases. This label change will likely position JAK inhibitors as a second line to other available agents.

These updated warnings represent issues surrounding accelerated FDA drug approvals that have recently drawn sharper scrutiny. To learn more, visit here.