Antibiotic Trial Continues Despite Reported Threat to Children

A new antibiotic that has been found to cause four times the average rate of acute liver failure in adults continues in a trial for more than 900 children worldwide, despite criticism from a U.S. Food and Drug Administration official and a study consultant. The drug, Ketek (internationally known as Telithromycin) is manufactured by Sanofi-Aventis, a French pharmaceutical firm with U.S. headquarters in New Jersey. The company has defended the antibiotic as safe when used as directed. "How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" asks Dr. Rosemary Johann-Liang, of the FDA's Office of Drug Safety, in a memo uncovered by the Times. Duke University infectious disease specialist Dr. Danny Benjamin echoes the concern, calling the pediatric trial "hard to support." Benjamin is especially critical of testing the antibiotic for routine ear infections at a time when antibiotics are less frequently recommended for pediatric treatment. Yet, the FDA's own website continues to promote the pediatric trial.


Sanofi-Aventis announced on June 8, 2006, after the flurry of negative reports, that it was voluntarily ceasing the trial of this antibiotic on children.