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FDA Weighs Fate of Antibiotic Ketek

Expert Panel Hears Testimony on Safety of Controversial Drug
By
WebMD Health News
Reviewed by Louise Chang, MD

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 bronchitis, sinusitis, and pneumonia. 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 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.

Reports of Liver Injury

Sanofi Aventis, which manufactures Ketek, reported to the FDA 212 cases of liver injury in patients who took the drug over the last two and a half years. Company and agency experts characterize the reports as initial signals of both minor and severe injuries that cannot be reliably blamed on the drug. Sanofi Aventis is a WebMD sponsor.

Company officials argued Thursday that the injuries occurred in 6 million uses of Ketek and that the drug, known generically as telithromycin, carries about the same overall risk as similar antibiotics.

"It's a drug with a signal of [liver] injury, but we always have to put it in perspective," said James H. Lewis, professor of medicine at Georgetown University, who testified on behalf of the company. "Take your pick of antibiotics, they are all associated with liver injury."

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