... New Safety Concerns about Zyvox FDA Patient Safety News: Show #64, June 2007 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 / Safety / MedWatch / SafetyInformation / SafetyAlertsforHumanMedicalProduct / ucm152993.htm FDA Patient Safety News is available at www.fda.gov / psn ...

... Section Contents Menu Drug Safety and Availability Postmarket Drug Safety Information for Patients and Providers Drug Safety Information for Healthcare Professionals Communications about Ongoing Safety Reviews Early Communications About Ongoing Safety Reviews Healthcare Professional Sheets Public Health Advisories (Drugs)-Information for Healthcare Professionals: Linezolid (marketed as Zyvox) FDA ALERT [3 / 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 ...

... Providers Section Contents Menu Drug Safety and Availability Postmarket Drug Safety Information for Patients and Providers Index to Drug-Specific Information Approved Risk Evaluation and Mitigation Strategies (REMS) Postmarketing Safety Evaluation of New Molecular Entities: Final Report Drug Safety Information for Healthcare Professionals-Linezolid (marketed as Zyvox) Information FDA ALERT [3 / 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 ...

... Medical Products 2005 Safety Alerts for Human Medical Products 2004 Safety Alerts for Human Medical Products 2003 Safety Alerts for Human Medical Products 2002 Safety Alerts for Human Medical Products 2001 Safety Alerts for Human Medical Products 2000 Safety Alerts for Human Medical Products-Zyvox (linezolid) Audience: Infectious disease specialists, other healthcare professionals [Posted 03 / 16 / 2007] FDA notified healthcare professionals 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 in the treatment of seriously ill patients with intravascular catheter-related bloodstream infections including those with catheter-site infections. 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 ...