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New Safety Concerns about Zyvox

Posted on April 29, 2008

FDA has issued an alert to health professionals on emerging safety concerns about the antibiotic Zyvox (linezolid). A recent clinical study compared Zyvox with vancomycin, oxacillin or dicloxacillin in patients with catheter-related bloodstream infections or catheter site infections. The study showed that patients on Zyvox had a higher chance of death than with any of the other drugs, and that the increased risk occurred in patients infected with Gram negative bacteria.

Healthcare professionals should note that Zyvox is not approved to treat Gram negative infections, nor is it approved for catheter-related bloodstream infections or catheter-site infections.

FDA will continue to evaluate this study, along with other information about Zyvox, and will update the alert as more information becomes available.

Additional Information:

FDA MedWatch Safety Alert. Zyvox (linezolid). March 16, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zyvox

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