FDA Panel Recommends Limited Use for Ketek
As regular readers know, I’ve been following the developments related to Ketek all year. Now, it seems the FDA advisory committee has recommended that Ketek only be used for certain life-threatening indications.
FDA Panel Hits Antibiotic For Bronchitis, Sinusitis - Forbes.com:
Basically, the committee recommended a black box warning on Ketek for its use in community acquired pneumonia which can be potentially life-threatening. The vote on this aspect was 16 to 3 that for community-acquired infections that Ketek should still be available.
They voted 17 to 2 that the the benefits did not outweigh risks for other indications such as sinusitis and bronchitis. These indications are not as serious and can be treated with other drugs. It will be interesting to see if the FDA rescinds the approval of Ketek for these indications. I think that is very likely to happen. For those out there interested in the chemical structure here it is.
Bottom line was that the drug is effective and can be used in certain indications but that physicians and the patient should be aware of the potential problems. Again, I applauded this recommendation; the risks vs reward must be weighed not for the drug itself but based on the exact indication.
Other Resources
FDA Search Results: ketek (sorted by date with most recent at the top)
Aventis Pharmaceuticals -Ketek - June 2006 prescribing information
Patient Information Sheet: Telithromycin (marketed as Ketek) (from FDA.gov)
ketek - Yahoo! Search Results
ketek - Google Searchimage
Technorati Tags: antibiotics, drug safety, FDA, Ketek, Sanofi-Aventis, telithromycin
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