Pfizer
March 23, 2007
Pfizer issued and important drug warning for Zyvox® (linezolid njetion, tablets and oral suspension) resulting from findings from an investigational clinical study in seriously ill patients with catheter-related bloodstream infections, including those with catheter site infections.
Although the study met its primary endpoint (microbiologic cure in gram-positive infections), a moratlity imbalance was seen in patients treated with linezolid relative to comparator (vancomycin/dicloxacillin/oxacillin).
While causality has not been established, this observed imbalance occurred primarily in linezolid-treated patients in whom either gram-negative pathogens, mixed gram-negative and gram-positive pathogens, or no pathogen were identified at baseline, but was not seen in patients with gram-positive infections only.
Pfizer has issued the following updates on its product label:
- Linezolid has no clinical activity against gram-negative pathogens and is not indicated for the treatment of gram-negative infections.
- It is critical that specific gram-negative therapy be initiated immediately if a concomitant gram-negative pathogen is documented or suspected.
- Linezolid is not approved and should not be used for the treatment of patients with catheter-related bloodstream infections or catheter-site infections.
