WASHINGTON, May 1 (Reuters) - The U.S. Food and Drug Administration said on Thursday that Amgen Inc (AMGN.O) and Wyeth’s WYE.N Enbrel arthritis drug will carry a warning about the risk of serious infections that can lead to hospitalization or death.
The companies had announced the new warning — a so-called black box — in March. Enbrel’s label now warns patients and doctors about tuberculosis, bacterial sepsis and other infections in patients taking the drug.
The same dangers were previously printed in bold-face type in Enbrel’s package insert label.
“Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel should be discontinued,” the FDA said in a statement on its Web site.
Amgen and Wyeth both market the drug in North America. (Reporting by Susan Heavey, editing by Dave Zimmerman)