With an apparent view toward expanding the market for Ketek®, Sanofi-Aventis launched four (4) clinical trials designed to test the effectiveness of Ketek® in young children and adolescents. These clinical trials were designed to enroll up to 4,000 infants, children and adolescents for the purpose of comparing Ketek® to older, traditional antibiotocs and penicillin for the treatment of ear infections and tonsillitis.

In two of the four clinical trials, infants and children ranging in age from six months to six years or less were being enrolled. In those trials, Ketek® was being compared to traditional antibiotics (cefuroxine axetil and azithromycin) for the treatment of Otis Media, i.e. ear infections. Those two clinical trials, identified as NCT00174811 and NCT00315003, were launched in 2005.

Two additional clinical trials designed to test the efficacy of Ketek® in the treatment of tonsillitis were also launched by Sanofi-Aventis. The first of such trials, identified as NCT00315042, enrolled infants and children between the ages of six months thirteen years and was designed to compare Ketek® against penicillin. The second, identified as NCT00315549, enrolled adults and adolescent children over the age of thirteen years. This clinical trial was also designed to compare the efficacy of Ketek® against penicillin.

All of these trials were halted when concerns surfaced over the safety of Ketek®, particularly since the conditions for which Ketek® was being tested in children, namely ear infections and tonsillitis, were not life-threatening. In the words of one FDA official, "How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" Dr. Rosemary Johann-Liang, an official in the Office of Drug Safety at the agency, wrote in one of the memorandums, a copy of which was obtained by The New York Times.”[1]

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