Federal Advisory Panel Urges Limits and Warnings for Antibiotic Ketek

Weitz and Luxenberg is no longer accepting Ketek cases.

December 18, 2006--At the conclusion of Friday’s review of Ketek’s safety at a joint meeting of the FDAs Drug Safety and Risk Management Advisory Committee and the Anti-infective Drug Advisory Committee, the panel members urged that Ketek be limited in the way it is prescribed and requested that stronger warnings be made on its labeling information.

Though the panel stopped short of removing Ketek from the market, it voted to restrict its use.

The experts voted 17 to 2 against the continued use of Ketek in the treatment of more minor conditions such as bacterial exacerbations of sinusitis and bronchitis. They felt the risks outweighed the benefits in this patient population, citing data showing that these conditions often resolve on their own without treatment.

Additionally, the panel voted 16 to 3 to continue to allow Ketek’s use in the treatment of mild to moderate community acquired pneumonia--but only as second line treatment.

The panel members also recommended the inclusion of a black box warning for the increased risk of liver failure, exacerbations of myasthenia gravis, visual disturbances and loss of consciousness.

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