Dr. David Graham, the FDA's chief whistleblower on unsafe drugs, concluded in an email last month that Ketek - made by a French drug company - should be withdrawn.
A message dated June 16, 2006 was a mistake. He wrote that it’s as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned. He added: 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.”
In addition to liver problems, Ketek may cause blurred vision and loss of consciousness.
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