May 1, 2008 / 6:44 PM / 11 years ago

US FDA: Amgen, Wyeth's Enbrel drug to carry warning

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)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below