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:

• A New FDA Warning for Tofacitinib (2021)
• FDA Warning on Tofacitinib (2019)
• “Tofacitinib: A Jak of All Trades”
• What Can We Conclude from Five Patients Treated with a Combination of Infliximab and Tofacitinib? | gutsandgrowth
• AGA Guidelines: Moderate to Severe Ulcerative Colitis | gutsandgrowth
• Tofacitinib: Where does it Fit in UC Treatment Algorithm?
• AGA Guidelines on the Management of Mild-to-Moderate Ulcerative Colitis
• Tofacitinib for Induction and Maintenance of Ulcerative Colitis
• Latest on Tofacitinib for Refractory Ulcerative Colitis
• Tofacitinib –a JAK Inhibitor for UC