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FDA Approves Vibativ for Certain Bacterial Pneumonias

For hospital-acquired and ventilator-associated S. aureus when other treatments aren't suitable

MONDAY, June 24 (HealthDay News) -- The antibiotic Vibativ (telavancin) has been approved by the U.S. Food and Drug Administration to treat hospital-acquired and ventilator-associated bacterial pneumonia caused by Staphylococcus aureus bacteria when other treatments aren't suitable.

Vibativ's safety and effectiveness were evaluated clinically among 1,532 people. The studies found the drug to be about as effective in treating S. aureus pneumonia as another approved antibiotic, vancomycin.

However, the studies found that more people treated with Vibativ died if they also had kidney problems, compared to kidney patients who took vancomycin. The FDA said it would add this information to Vibativ's label. The most common clinical side effect of Vibativ was diarrhea.

Vibativ was first approved in 2009 to treat skin infections. The drug is marketed by San Francisco-based Theravance Inc.

More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm358209.htm )