The Food and Drug Administration has updated the boxed warning label of all tumor necrosis factor–alpha blockers to include information on the risk of infection from Legionella and Listeria.
The warnings and precautions sections of the drug labels also have been revised to include information on the risk for serious infections that could lead to death from multiple disease-causing pathogens.
The TNF blockers that will receive the warnings include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab), according to the FDA announcement.
The FDA advised that risks and benefits should be weighed before initiating TNF blocker therapy in patients with chronic or reoccurring infections, or in patients with conditions that may put them at higher risk for infection.
Reports of serious adverse events associated with these and other drugs should be reported to MedWatch at 800-332-1088.