FDA Slaps Restrictions on JAK Inhibitors Over Serious Safety Risks

Medpage Today (Sept 1, 2021), Full text: FDA Slaps Restrictions on JAK Inhibitors Over Serious Safety Risks

— Use for inflammatory conditions limited to those who fail on TNF blockers

An excerpt:

The FDA has finished its review of a large postmarketing safety study of tofacitinib (Xeljanz, Xeljanz XR), and its conclusions do not bode well for the popular drug and the larger class of JAK inhibitors.

Data from the trial revealed increased risks for serious heart-related events — including myocardial infarction (MI) and stroke — as well as a higher risk for cancer, blood clots, and death. Even the lower 5-mg dose of tofacitinib turned up an increased risk of blood clots and death in the final analysis, the agency noted.

FDA is requiring new and updated warnings for tofacitinib, as well as two other arthritis medicines in the JAK inhibitor class — baricitinib (Olumiant) and upadacitinib (Rinvoq)…

Treatment with the JAK inhibitor was associated with an increased risk for major adverse cardiac events (MACE), including MI, cardiovascular death, and stroke (HR 1.33, 95% CI 0.91-1.94), which missed criteria for non-inferiority, as well as a higher risk for cancer (HR 1.48, 95% CI 1.04-2.09).

Related blog posts -Tofacitinib:

1 thought on “FDA Slaps Restrictions on JAK Inhibitors Over Serious Safety Risks

  1. Pingback: IBD Shorts: Tofacitinib Safety, Vit D post-op, EIM with Vedolizumab | gutsandgrowth

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.