The FDA expanded the approved use of the antibiotic Vibativ (telavancin) to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus. Vibativ should be used for the treatment of HABP/VABP only when alternative treatments are not suitable.
Bacterial pneumonia is a lung infection that can be caused by many different types of bacteria. Vibativ is approved only to treat S. aureus, not other bacteria that cause pneumonia. HABP/VABP, also known as nosocomial pneumonia, is a particularly serious lung infection because patients in the hospital and especially those on ventilators are often already very sick and usually cannot fight the infection.
“Today’s approval demonstrates the FDA’s commitment to making available new therapeutic options to treat serious diseases like HABP/VABP, particularly for very ill patients who have exhausted or cannot take other available treatments,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Among patients presumed to test positive for S. aureus taken at baseline, mortality rates were comparable between the Vibativ and vancomycin treatment arms, except for patients who had pre-existing kidney problems.
During clinical trials, more patients with pre-existing kidney problems treated with Vibativ died compared to those treated with vancomycin. Vibativ can also cause new or worsening kidney problems in patients. This information has been added to Vibativ’s Boxed Warning.
Diarrhea was the most common side effect identified in the clinical trials.
See the FDA Announcement
See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who Is Liable and Why?