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FDA Says Aventis Failed To Act on Ketek Drug Fears

Nov 5, 2007 | ANNA WILDE MATHEWS | The Wall Street Journal

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.

In yesterday's letter, the FDA said visits from an Aventis contractor and the drug maker's own audits documented "serious protocol violations and regulatory noncompliance by multiple clinical investigators." The agency said it was "unable to find evidence" that the company either fixed the problems or threw the problematic doctors out of the study and told the FDA. The FDA also faulted Aventis for failing to make sure the study was properly conducted and for allowing unqualified investigators to participate in the trial.

Ketek and the safety study have been the subject of investigations by Congress. Rep. John Dingell (D., Mich.) said the letter "confirms that the company was aware the data in its study was compromised." Sen. Charles Grassley (R., Iowa) said the letter "starts to hold the drug maker accountable."

Sanofi-Aventis said it acted in good faith in conducting the study and intends to provide a detailed response to the FDA's letter, including steps it has taken to prevent similar problems. Last year, Sanofi-Aventis added a warning to Ketek's label about the potential for liver risk.