The U.S. Food and Drug Administration has updated the boxed warning for all tumor necrosis factor-alpha (TNF) inhibiting drugs, following its receipt of more than 100 cases of infections from the bacteria Legionella and Listeria.
TNF inhibitors such as Humira, Cimzia, Remicade, Enbrel and Simponi are licensed in the U.S. to treat rheumatoid arthritis, Chron’s disease, ulcerative colitis and a variety of other problems. While the risk for serious infection to occur exists with any immunosuppressive drug, a total of 80 cases of Legionella pneumonia have recently been reported to the FDA. Moreover, in four of these cases, the pneumonia was so severe that mechanical ventilation was warranted. In five of the cases, intensive care treatment was even required. Additionally, the FDA has also cautioned patients that Listeria infections have also occurred in patients during clinical trials of TNF inhibitors.
The FDA has advised healthcare providers to consider the risks and benefits associated with use of these drugs prior to using them, especially in patients who have a history of chronic infections or any history of disorders associated with immunosuppression.
