Dr. David Graham of the Food and Drug Administration's drug safety office wrote in an e-mail to another official last month that the agency's 2004 approval of the drug, produced by Sanofi-Aventis, was a mistake, The New York Times reported.
"It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned," Graham wrote.
The Times said Graham's e-mail message is one of dozens provided to the newspaper that reveal a fierce debate within the FDA over the safety of Ketek.
Shortly after Graham's e-mail message, the FDA announced changes to Ketek's label, emphasizing that the drug could in rare circumstances cause serious liver injury, liver failure and death, the newspaper said.
"We continue to believe that the benefits of Ketek outweigh the risks when it is used as directed for its approved indications," Melissa Feltmann, a spokeswoman for Sanofi-Aventis, told the Times.