Off-Label Use of Linezolid Linked to Increased Death Risk

Yael Waknine


March 19, 2007

March 19, 2007 — Use of linezolid ( Zyvox ; Pfizer, Inc) to treat patients with catheter-related bloodstream infection may be linked to an increased risk for mortality, the US Food and Drug Administration (FDA) warned healthcare professionals Friday.

The warning was based on data from an open-label randomized trial of 726 patients (including those with catheter-site infections) showing that linezolid was linked with an increased risk for death compared with vancomycin, oxacillin, or dicloxacillin, according to an alert from MedWatch, the FDA's safety information and adverse event reporting program.

Investigators also determined that the risk was associated with the type of infection; the death-rate disparity at 84 days was highest for those with gram-negative infections receiving linezolid vs comparator drugs (26.7% vs 9.1%). The risk increase was about double for those with a combination of gram-negative and -positive infections (34.8% vs 17.9%) and for those not infected at the beginning of the study (26.3% vs 13.0%); no increase in mortality risk was observed for patients infected with gram-positive organisms alone (16.7% vs 17.2%).

The FDA reminds healthcare professionals that linezolid is not approved for the treatment of catheter-related bloodstream infections or catheter-site infections. It also is not indicated for the treatment of gram-negative infections, and immediate initiation of appropriate therapy is advised if such infection is known or suspected.

Approved indications for the antibiotic include vancomycin-resistant Enterococcus faecium infection, complicated skin/skin structure infection (including diabetic foot infection) without concomitant osteomyelitis, uncomplicated skin/skin structure infections, nosocomial pneumonia, and community-acquired pneumonia.

Adverse events potentially related to use of linezolid should be reported to the drug's manufacturer and to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.


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