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Lung Disease & Respiratory Health Center

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FDA Weighs Fate of Antibiotic Ketek

Expert Panel Hears Testimony on Safety of Controversial Drug

Reports of Liver Injury continued...

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."

More Serious Cases

But an analysis commissioned by the agency found 35 cases of severe injuries -- including seven resulting in a liver transplant or death -- that analysts say were very likely attributable directly to Ketek.

"What we have is a higher number of these hospitalized patients" than are seen with other drugs, said William Lee, MD, director of the Clinical Center for Liver Diseases at the University of Texas Southwestern Medical Center and one of the analysts commissioned by the FDA.

The advisory committee is scheduled Friday to consider other data linking Ketek to other side effects, including temporary blindness and abnormal heart rhythms.

Senate Criticism

The meeting is taking place against a backdrop of stark criticism from the Republican chairman of the Senate Finance Committee, which has spent the last year investigating the FDA's handing of Ketek's approval.

A committee report released Wednesday concluded that FDA officials did not tell the advisory panel in 2003 that a Sanofi Aventis safety study, called 3014, was flawed.

"In sum, the FDA did not ensure that the public received accurate, science-based information regarding the Ketek (application)," Sen. Charles E. Grassley, R-Iowa, wrote in the report.

"If the FDA could not find a way to present only accurate, science-based information, the FDA should not have presented study 3014 publicly, or alternatively, should have postponed or canceled the [Senate committee] meeting," the report said.

FDA officials have said they did not take that study into account when they approved Ketek. They instead relied on European safety studies attempting to measure Ketek's safety on the market in France, Germany, and other countries.

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