American College of Rheumatology Comment on JAK Inhibitors and FDA Drug Safety Communication September 09, 2021 Statement from ACR President David Karp, MD, PhD “The ACR is aware of the recent "Black Box" addition by the Food and Drug Administration (FDA) to the product insert for three Janus Kinase inhibitors (JAK inhibitors): tofacitinib, baricitinib, and upadacitinib. We are reviewing the data as they are made available so that we may more clearly identify the risks to patients and are engaging in conversations with the FDA. At this time, we do not have any specific recommendations or changes in our guidelines. It is important to remember that the diseases that are treated with JAK inhibitors are associated with serious long-term sequelae if untreated. For each FDA approved indication, JAK inhibitors have been shown to make a dramatic improvement in disease activity. All treatments can have adverse events and this recent "Black Box" warning is evidence of continued understanding of the risks involved. The ACR recommends continued discussion between the patient and the provider regarding the best option for the patient moving forward." Access the FDA drug safety communication Media Contact: Jocelyn Givensjgivens@rheumatology.org 404-929-4810 ###Founded in 1934, the American College of Rheumatology (ACR) is a not-for-profit, professional association committed to advancing the specialty of rheumatology that serves over 7,700 physicians, health professionals, and scientists worldwide. In doing so, the ACR offers education, research, advocacy and practice management support to help its members continue their innovative work and provide quality patient care. Rheumatology professionals are experts in the diagnosis, management and treatment of more than 100 different types of arthritis and rheumatic diseases.