FDA Panel Hits Antibiotic For Bronchitis, Sinusitis

Ketek is used to treat certain types of bronchitis, sinusitis and pneumonia. But since its approval in 2004, hundreds of cases of liver damage, loss of consciousness and other side effects have been reported. According to the Wall Street Journal, U.S. doctors wrote more than 3.35 million prescriptions for the antibiotic in 2005, bringing in $193 million in revenues.

The drug and the related approval process have been haunted by criticism, however.

In June, the drug's maker, Sanofi-Aventis, agreed to update Ketek's labeling to reflect the possibility of severe liver damage.

Last month, a European Medicines Agency panel recommended that Ketek not be given to patients with a history of such liver conditions as hepatitis or jaundice.

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And during the first day of hearings Thursday, the FDA was forced to defend its use of post-marketing data from Europe to approve the drug.

The U.S. Senate Finance Committee is also investigating allegations of fraud involving clinical trials of Ketek and is looking into how the FDA handled Ketek-related safety issues, Bloomberg News reported.

Sen. Charles Grassley, an Iowa Republican, accused the FDA of withholding relevant information at the time of the drug's approval and has asked FDA Commissioner Dr. Andrew von Eschenback to respond by Jan. 17 to allegations that the agency had knowingly used fraudulent safety data to approve Ketek.

Committee members themselves spoke of an arduous session that involved 13 pounds of reading material mailed to them before the briefing even began.

"It was a particularly challenging meeting for the two committees within the context of continued critical concerns for diminished interest in the development of anti-infective agents pharmaceutical agents in general and an increased concern for safety considerations for drugs in general," said Dr. John Edwards, acting chair of the Anti-Infective Drugs Advisory Committee.

"Antibiotics and all drugs have a certain amount of risk associated with them, and those of us who use drugs and prescribe drugs have a great concern for the possibility that the risks may occur in any given individual patient," Edwards added. "So, yes, we are cautious about the use of the drugs both specifically and in general. And much of the discussion today was around caution in using anti-infectives."

More information

For more on the briefings, visit the FDA.