Results of a clinical trial comparing linezolid (Zyvox, Pfizer) with vancomycin, oxacillin, or dicloxacillin show that patients treated with linezolid had a higher mortality rate compared with patients treated with other antibiotics.
Results of a clinical trial comparing linezolid (Zyvox, Pfizer) with vancomycin, oxacillin, or dicloxacillin show that patients treated with linezolid had a higher mortality rate compared with patients treated with other antibiotics. The chance of death was higher in patients infected with gram-negative organisms or a mix of gram-negative and gram-positive organisms, or in those patients who had no infection when they entered the study. Patients were being treated for intravascular catheter-related bloodstream infections, including catheter-site infections. Patients treated for gram-positive infections showed no increase in mortality. The FDA reminds practitioners that linezolid is not approved for the treatment of gram-negative catheter-related infections.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.