Published Research Download
Analysis of Spontaneous Postmarket Case Reports Submitted to the FDA Regarding Thromboembolic Adverse Events and JAK Inhibitors
- 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.