Medication Adverse Event Alert
March 19, 2007
| MEDICATION: | Zyvox® (linezolid), Pharmacia |
| DOSAGE FORM: | Oral tablets, powder for oral suspension, injection |
| STRENGTHS: | 400mg and 600mg tablets, 100mg/5ml suspension, 2mg/mL injection |
| ISSUE: | New FDA safety concerns about linezolid use in gram negative infections |
The following was excerpted from the FDA News web site on March 16, 2007:
"FDA is issuing this alert to advise you 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 (comparator antibiotics) in the treatment of seriously ill patients with intravascular catheter-related bloodstream infections including those with catheter-site infections. In this study, 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. FDA is currently evaluating the new study along with other information about linezolid.
Considerations for Physicians and Other Health Care Professionals
Linezolid is approved for the treatment of vancomycin-resistant Enterococcus faecium infections, nosocomial pneumonia, community acquired pneumonia, uncomplicated skin and skin structure infections, and complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis.
Physicians and other healthcare professionals should consider the information from this new study when deciding whether to prescribe linezolid. In this study, mortality was higher in the linezolid arm:
In patients infected with Gram negative organisms alone
In those infected with both Gram positive and Gram negative organisms
In patients in whom no infection was observed when they entered the study
In patients with only Gram positive infections, however, no difference in mortality was seen between the linezolid and comparator arms. Physicians and other healthcare professionals are reminded that:
Linezolid is not approved for the treatment of catheter-related bloodstream infections or catheter-site infections
Linezolid is not indicated for the treatment of Gram negative infections. If infection with Gram negative bacteria is known or suspected, appropriate therapy should be started immediately
Current Status
Linezolid is not approved by the FDA for the treatment of catheter-related bloodstream infections or catheter-site infections. We are reviewing the information mentioned here, along with other information on the effects of linezolid to further evaluate the observed findings. We have not yet come to any final conclusions about the implications of this new study for linezolid. We intend to continue evaluating all available information and, if the review reveals additional important information to share, we will notify healthcare providers and patients."
