FDA Officials Disagreed with Ketek Approval

July 2006

A Food and Drug Administration (FDA) debate is heating up over the safety of the antibiotic, Ketek. According to internal FDA e-mails, Ketek’s approval was a mistake and the drug should be taken off the market immediately.

An FDA spokeswoman reassured that every issue or question raised during Ketek’s trial and afterward was reviewed by the nation’s top doctors both internally and externally. However, several e-mails have appeared stating that many safety officials within the FDA expressed serious concern with the antibiotic.

Since Ketek’s approval in 2004:

• 14 adults suffered liver failure
• Four of the fourteen died
• others suffered serious liver injury

Although Ketek’s label has been changed to include a warning about severe liver damage, it is still is available for use. This is despite suggestions by officials to remove the antibiotic from the market.

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