FDA Alert: Linezolid (Zyvox) And Gram-Negative Infections
The FDA has alerted prescribers of new safety concerns about linezolid (Zyvox generic, Pfizer).
A recent open-label, randomized trial compared linezolid with vancomycin (Vancocin, Viro Pharma), oxacillin (Bactocill, SmithKlineBeecham; Prostaphlin, Apothecon), or dicloxacillin (Dycill, GlaxoSmithKline; Dynapen, Apothecon) in seriously ill patients with intravascular catheter-related bloodstream and catheter-site infections. Patients receiving linezolid had a higher chance of dying than those treated with any of the comparator antibiotics.
Patients with gram-positive infections experienced no difference in mortality according to their antibiotic treatment; however, the mortality rate was higher in patients receiving linezolid who were infected with gram-negative organisms alone, in those who had both gram-positive and gram-negative organisms, and in those who had no infection when they entered the study.
Linezolid drug is not indicated for the treatment of catheter-related bloodstream infections, catheter-site infections, or gram-negative infections. If infection with gram-negative bacteria is known or suspected, appropriate therapy should be started immediately.
