Table V.
Summary of FDA-imposed boxed warnings about infections with TNF antagonists.75
| • Increased risk of serious infections that may lead to hospitalization or death |
| • Treatment should be discontinued in the case of serious infections or sepsis |
| • Risk of active TB, including reactivation of latent TB. Latent TB should be treated before starting TNF antagonists |
| • Risk of invasive fungal infections (including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis) |
| • Risk of infection (bacterial and viral) with opportunistic pathogens |
| • Monitor patients for infections, including TB, even when an initial test for latent TB was negative |