ACR Comments on JAK Inhibitors and FDA Announcement Save

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