Ketek's Approval Worried FDA Officials

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In recent weeks, dozens of e-mails between internal FDA officials were turned over to the New York Times. The e-mails show that at least four FDA officials had serious reservations about the safety of the popular antibiotic, Ketek, which was recently forced to change its label to include stronger warnings.

Dr. David Graham, part of the FDA's drug safety office, wrote in a message dated June 16 that the agency's approval of Ketek (telithromycin) was a mistake: "It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned." Referring to reports of adverse drug reactions voluntarily submitted to the FDA, Dr. Graham continued, "We don't really know if the drug works; no one is claiming it works better than other, safer drugs; and we're flying blind as far as safety goes, except for our own A.D.R. data that suggests telithromycin is uniquely more toxic than most other drugs." Dr. Graham believed that the FDA should recommend Ketek's "immediate withdrawal."

Ketek has been associated with an increased risk of severe liver damage and death, as well as vision problems and loss of consciousness.