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| 11/18/2008 |
FDA: Antibiotic May Be Linked to Deaths
(New York, NY) -- An experimental antibiotic may be linked to several deaths in patients treated for complicated skin infections. FDA reviewers made the assertion in a report about Theravance's telavancin. The report said telavancin worked just as well as an older antibiotic, vancomycin, in treating complicated skin infections. But, the FDA staff said the panel should discuss whether the drug causes kidney damage or birth defects. Animal testing has shown limb malformations. In looking at the deaths of nine people taking telavancin and nine patients taking the older drug, the FDA team determined that some of the deaths "possibly" were related to telavancin.
In a summary for the panel to consider, Theravance said telavancin would be an important drug because it shows the capability to fight potentially deadly bacteria that resist older antibiotics. They said kidney impairment was the only "quantifiable risk" and that as long as a patient's kidney function was monitored the benefits of the drug far outweighed the risks. The FDA team will ask the panel if the data shows the safety and effectiveness of telavancin for treating complicated skin infections. They also want to know if the benefits outweigh the risks for certain pregnant women. The FDA will have the final say on the drug's approval, but they generally follow the panel's recommendations. |
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