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Dec. 14, 2006 -- An FDA panel is getting ready to decide whether to recommend that a widely used antibiotic be taken off the market.
The drug, known as Ketek, is used to treat respiratory tract infections like bronchitisbronchitis, sinusitissinusitis, and pneumoniapneumonia. Doctors have written an estimated 6 million prescriptions for the drug since it was approved in April 2004.
But the FDA is reconsidering that approval because of reports suggesting the drug could carry a higher risk of severe liver failureliver failure and other dangerous side effects than similar antibiotics.
A panel of experts is holding two days of hearings on Ketek safety. The hearings began Thursday. A recommendation is expected to be made on Friday.
This week, a Senate committee investigation blasted agency officials for their handling of Ketek's original approval. A committee report accuses officials of withholding details of a tainted Ketek safety study from the panel in 2003 as it was advising the FDA on the drug. The episode has led some FDA scientists to sharply criticize the decision to approve Ketek.
Ketek was never shown to be more effective than other antibiotics at curing infections. The FDA requires only that new antibiotics show evidence of "noninferiority" to existing drugs. The rationale, experts say, is to help ensure a steady stream of available drugs to combat antibiotic resistance.
The drug was judged to be as safe as other antibiotics when it was approved in 2004, based on premarket studies. But reports of a possible pattern of liver injuries while the drug has been sold in the U.S. prompted the FDA to reopen deliberations over Ketek.
"Ketek is being triggered because of the safety concerns that have arisen," said John Jenkins, MD, director of FDA's Office of New Drugs.