FDA warns of heart-related events, cancer, blood clots, and death for JAK inhibitors
The FDA on Wednesday wrapped up its long-awaited review of Pfizer’s large, randomized trial evaluating the safety of its JAK inhibitors Xeljanz and Xeljanz XR compared to tumor necrosis factor blockers like Enbrel and Humira. The results aren’t good and spell trouble for more than just Pfizer’s drugs.
The agency said the trial results show there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with these arthritis and ulcerative colitis medicines, and it’s updating JAK inhibitor labels while limiting their use to certain patients who are not treated effectively or who experience severe side effects with the TNF blockers.
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