JAK inhibitors dealt blow with FDA review outcome

A US Food and Drug Administration (FDA) review of a large clinical trial has led the agency to conclude that JAK inhibitors lead to an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death.

The trial compared Pfizer’s (NYSE: PFE) arthritis and ulcerative colitis medicines Xeljanz (tofacitinib) and Xeljanz XR (tofacitinib), which fall in the JAK inhibitor class, and another type of drug called tumor necrosis factor (TNF) blockers, in patients with rheumatoid arthritis.

Final results also showed an increased risk of blood clots and death with the lower dose of Xeljanz. A prior drug safety communication based upon earlier results from this trial, reported an increased risk of blood clots and death only seen at the higher dose.