Zyvox (linezolid) Linked to Death Among Patients

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals of new emerging safety concerns
about Zyvox (linezolid) from a recent clinical study. This open-label,
randomized trial compared linezolid to vancomycin, oxacillin, or
dicloxacillin in the treatment of seriously ill patients with
intravascular catheter-related bloodstream infections including those
with catheter-site infections. Patients treated with linezolid had a
higher chance of death than did patients treated with any comparator
antibiotic, and the chance of death was related to the type of organism
causing the infection. Patients with Gram positive infections had no
difference in mortality according to their antibiotic treatment. In
contrast, mortality was higher in patients treated with linezolid who
were infected with Gram negative organisms alone, with both Gram
positive and Gram negative organisms, or who had no infection when they
entered the study.

Linezolid is not approved for the treatment of catheter-related
bloodstream infections, catheter-site infections, or for the treatment
of infections caused by Gram negative bacteria. If infection with Gram
negative bacteria is known or suspected, appropriate therapy should be
started immediately.