It has been over 9 months since Dr. David Graham, an FDA safety official stated in his June 16, 2006 memo that Ketek should be withdrawn. He said approval of the drug was a “mistake” and contended that “every principle concerning the review and approval of new drugs was abandoned or suspended where [Ketek] is concerned.”
Dr. Graham believes the benefits of Ketek are outweighed by the risk of serious liver problems.
Dr. Graham may not be alone in believing that Ketek should be recalled. Dr. Charles Cooper, Dr. David Ross and Dr. Rosemary Johann-Liang all have expressed serious doubts about the safety of Ketek.
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