FDA Announces Label Change to Warnings for TNFα Blockers
Label revised to reflects risk of Legionella and Listeria infection
WEDNESDAY, Sept. 7 (HealthDay News) -- Labels for all tumor necrosis factor-alpha (TNFα) blockers have been revised to include the risk of infection from Legionella and Listeria, according to a safety alert issued Sept. 7 by the U.S. Food and Drug Administration.
The label change came about after a review of currently available data revealed reports of serious infections due to Legionella and Listeria, some resulting in fatalities, in patients taking TNFα blockers, which can compromise the body's immune system and reduce its ability to fight infection.
A review of the FDA's Adverse Event Reporting System database found that 80 patients developed Legionella pneumonia after taking a TNFα blocker between 1999 and 2010; there were 14 deaths. A literature search turned up reports of 23 patients who developed the same infection after taking TNFα-blockers; three patients died. Another literature search revealed reports of 26 cases of Listeria infection in patients taking TNFα blockers; seven patients died.
According to the FDA, "the pathogens Legionella and Listeria have been added to the Boxed Warning for the entire class of TNFα blockers, so that health care professionals are aware that these pathogens can cause serious and potentially fatal outcomes in patients treated with TNFα blockers."