Ketek: Why Did the FDA Approve This Deadly Antibiotic?
May 18, 2006
Five years ago, the FDA did not approve Ketek, an antibiotic with the generic name telithromycin, for use in the United States. In their decision, they cited toxic effects such as liver damage.
Arrests and Prison Terms
However, in response to the FDA's decision, the drug's manufacturer Sanofi-Aventis launched a new trial, study 3014, to test its safety. Study 3014 included fabricated data, and led to arrests and prison terms, forcing the FDA to throw out the results. The study is still defended as legitimate by Sanofi-Aventis.
Still Cited TodayDespite this, the FDA reversed its original decision and approved Ketek, based on previous data collected and rejected by the FDA, along with smaller studies and the drug's European safety record. Study 3014 is still being cited by medical journals to back up Sanofi-Aventis' claim that Ketek is safe.