The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with Xeljanz and Xeljanz XR (tofacitinib).
Xeljanz® and Xeljanz XR® are used for the treatment of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Workers may develop various forms of arthritis due to cumulative or acute trauma, or an occupational injury could aggravate pre-existing inflammatory joint disease that may have been previously mild. For these reasons, Xeljanz and Xeljanz XR could appear in workers’ comp claims.
While the final results of the safety trial are not yet available, tofacitinib is a tumor necrosis factor (TNF) inhibitor that works by decreasing activity of the immune system, as an overactive immune system contributes to these conditions. However, decreasing the activity of the immune system can come with negative side effects, which is why the safety trial was initially launched.
When the FDA first approved tofacitinib in 2017, they required the manufacturer to conduct the safety clinical trial in patients with rheumatoid arthritis who were taking methotrexate to evaluate the risk of serious heart-related events, cancer, and infections.
The trial studied two doses of tofacitinib, 5 mg twice daily and a higher 10 mg twice daily dosage, in comparison to another TNF inhibitor. Patients in the trial were required to be at least 50 years old and have at least one cardiovascular risk factor.
After reviewing preliminary results in 2019, the FDA previously warned healthcare professionals twice that year that Xeljanz and Xeljanz XR can increase the risk of blood clots and death with higher than 10mg twice daily dosages, resulting in a new boxed warning.
The extent of these new heart-disease and cancer risks is not fully known, and the FDA will continue to evaluate the clinical trial results and work with the drug manufacturer to obtain further information.
Patients should not stop taking these medications without first consulting with their provider. Providers should consider the benefits and risks of a patient using Xeljanz or Xeljanz XR before deciding to continue or discontinue use.