New FDA Label Limits Use of Sanofi-Aventis's Ketek

by Mark S. Senak
EyeOnFDA.com



The FDA announced the issuance of a new label for Ketek (telithromycin) that strips away two indications for use of the drug - acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis - and retaining the sole remaining indication, treatment of community acquired pneumonia of mild to moderate severity (acquired outside of hospitals or long-term care facilities).

The phrasing around removal of the two prior indications was that the FDA "has determined that the balance of benefits and risks no longer support approval of the drug for these indications."

It is unclear whether this move will address concerns of Congressional critics. Also, the agency did not provide any insight in the press release on the topic as to how they came to that conclusion. What were the calculations that went into the new risk/benefit ratio and how did they differ from when the drug got those indications on its label.

This move may raise more questions for the agency than are answered by its action.

The FDA also posted a web page on Ketek.


Source: EyeOnFDA.com



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