FDA safety official called for halt to Ketek trial

A senior-level FDA safety official recently called for a halt to a clinical trial of the antibiotic Ketek in children, citing indications of the drug's unusual toxicity. Sanofi-Aventis has been testing Ketek as a therapy to fight ear infections and tonsillitis in children. But Dr. Rosemary Johann-Liang made it clear in a memo that the trial was taking unnecessary risks with their lives. "How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" she wrote in a memo obtained by The New York Times. Sanofi-Aventis says that they are in discussions with the FDA about the drug, which has been linked to a variety of cases of liver failure, blurred vision and loss of consciousness.

The FDA ignored early trial data on Ketek after it was revealed that the trial had been conducted fraudulently. Instead, it relied on actual experience with the drug in Europe. That decision has proved highly controversial. Safety officials at the agency have suggested that the FDA force the drug off the market or add warnings about the potentially fatal side effects presented by the therapy.

- read the New York Times article on Ketek