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US FDA: Amgen, Wyeth's Enbrel drug to carry warning
01 May 2008 18:40:55 GMT
Source: Reuters
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)
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