Sanofi-Aventis halted enrollment in a trial of the antibiotic Ketek yesterday but denied that it had anything to do with the same-day news reports of the dire safety warnings issued by a senior FDA official. Sanofi said the company merely wanted to make sure that it was conducting the trial in accordance with FDA requirements. That explanation was likely to quickly elicit scoffs from drug experts who have poured criticism on Ketek, an antibiotic which has been linked to liver failure in adults.
Sanofi researchers are exploring the use of Ketek as a therapy for ear infections and tonsillitis for children, which provoked one agency expert to call for a halt to the trials, saying they presented an unnecessary and severe risk to the thousands of children that were to be enrolled for the clinical study. A late-stage trial of Ketek was marred by fraud. The FDA said they ignored the data from that report, relying instead on the results tracked in Europe following the approval of Ketek.
- read the New York Times article [1] on Ketek
Links:
[1] http://www.nytimes.com/2006/06/09/health/09drug.html