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    Medication Event Alert May 1, 2008
The following was posted on the FDA Med Watch web site on May 1, 2008:
“Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel®. The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel®. Infections have included bacterial sepsis and tuberculosis. The ADVERSE REACTIONS section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel®. Healthcare professionals should screen patients for latent tuberculosis infection before beginning Enbrel®. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel® should be discontinued.”
A complete copy of the accompanying “Dear Healthcare Professional Letter” dated March 14, 2008 from Amgen and Wyeth Pharmaceuticals—including a copy of the updated BOXED WARNING—may be viewed at:
http://www.fda.gov/medwatch/safety/2008/AmgenDearHCPLetter.pdf |
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