FDA Requires New Boxed Warnings on JAK Inhibitors, Places Restrictions on Use

The impact on patients and the administrative burden on practices will likely increase, says Victoria Ruffing, RN-BC, the director of patient education at the Johns Hopkins Arthritis Center, Baltimore, adjunct faculty at the Johns Hopkins School of Nursing and an associate editor of The Rheumatologist. “I foresee even greater challenges for prior authorizations. Insurance companies will likely try to force the use of two TNFs before agreeing to a JAK inhibitor,” she says. “Also, many patients are going to be hesitant to start JAK inhibitors when they hear about this.”

References

1. FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions. U.S. Food & Drug Administration. Drug Safety Communication. 2021 Sep 1.
2. FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR). U.S. Food & Drug Administration. Drug Safety Communication. 2019 Jul 26.