FDA officials worried over Ketek

Wouldn't it be nice if the FDA put patient safety first, rather than rubber-stamping drug approvals? Turns out some staffers do, even if they're ignored. Internal FDA emails obtained by The New York Times show a federal drug safety official, Dr. David Graham, urging the withdrawal of the controversial antibiotic Ketek (telithromycin), which has caused liver damage and sometimes death in otherwise healthy patients. "It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned," Dr. Graham wrote in a June 16 message. "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 [adverse drug reaction] data that suggests telithromycin is uniquely more toxic than most other drugs." At least three other safety officials--including Dr. Charles Cooper, Dr. David Ross and Dr. Rosemary Johann-Liang --expressed serious reservations about the safety of Ketek. The FDA has finally announced changes to Ketek's label emphasizing that the drug can in rare circumstances cause serious liver injury, liver failure and death. More than five million prescriptions have been written for Ketek since its 2004 approval.

- take a look at this The New York Times article