Emails between FDA officials obtained by The New York Times reveal that agency staffers continue to have reservations about the safety of Ketek (telithromycin), Sanofi-Aventis' controversial antibiotic. Dr. David Graham, an official in the FDA's safety office, criticized the review process of Ketek and questioned the drug's safety and efficacy. "It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned," Graham wrote in an email. He concluded that Ketek should be withdrawn from the market. Late last month Sanofi-Aventis added new warnings to the drug, which has been linked to cases of liver damage. Sanofi-Aventis says the rewards still outweigh any risks associated with Ketek.
- here's the The New York Times report [1]
Links:
[1] http://www.nytimes.com/2006/07/19/health/19fda.html