Ketek Approved Despite Flawed Study

May 2006

The death of a 26-year-old construction worker who died from severe liver damage after taking the antibiotic Ketek has prompted a government investigation. An internal Food and Drug Administration (FDA) analysis reported ten cases of people sustaining liver failure after taking the antibiotic. Now documents have surfaced, including internal Aventis emails, piquing interest about a key clinical trial for Ketek, known as study 3014.

Aventis began the study in 2001 at the request of the FDA, due to concerns about liver damage, blurry vision and other possible side effects, after reviewing the company’s earlier trials. The FDA later declared that study 3014 had so many flaws that the data was not reliable. Despite the flawed study, the FDA went on to approve the drug to treat sinusitis, bronchitis and pneumonia in April 2004.

Sanofi-Aventis is the third largest drug manufacturer, and last year alone 3.35 million pescriptions were written for Ketek. Currently, the drug is being studied in children with ear infections and tonsillitis. Sanofi-Aventis maintains the drug is safe.

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