Published Research Download

Analysis of Spontaneous Postmarket Case Reports Submitted to the FDA Regarding Thromboembolic Adverse Events and JAK Inhibitors

JAK_Drug Safety.png

Key Points:
  • Potential thromboembolic safety concerns for baricitinib, a Janus kinase (JAK) inhibitor, were recently raised by the US FDA. 
  • The FDA has previously approved two other JAK inhibitors, tofacitinib and ruxoliti nib, but has not issued any warnings regarding thromboembolic safety signals for these two medications. 
  • A systematic review of the FDA’s Adverse Event Reporting System (FAERS) found elevated reporting for both tofacitinib and ruxolitinib for certain thromboembolic adverse events, suggesting the possibility of a class-wide issue.

...For full access to this free report, fill out the form