FDA Weighs Fate of Antibiotic Ketek
Expert Panel Hears Testimony on Safety of Controversial Drug
WebMD News Archive
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
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