FDA Says Aventis Ignored Reports of Problems in Ketek Safety Study

Article in the Wall Street Journal -- FDA Says Aventis Failed To Act on Ketek Drug Fears, by Anna Wilde Matthews.  Here's an excerpt:

The Food and Drug Administration said drug maker Aventis failed to act on reports of serious problems with a safety study on its antibiotic Ketek and didn't properly oversee the trial's conduct.

The FDA detailed its concerns in a letter posted yesterday on its Web site and sent to Sanofi-Aventis SA, the successor company after a merger. Ketek, which has been linked to a risk of liver damage, was approved by the FDA in 2004, though the agency has said it didn't rely on the questionable safety study in approving the drug.

The doctor who ran the site that enrolled the most patients in the study ultimately pleaded guilty to fraud. The study was supposed to answer questions about whether the drug was tied to side effects including liver damage.

BGS