Ketek has not been recalled but the food and Drug administration (“FDA”) issued several warnings to Sanofi-Aventis, Ketek’s manufacturer. The FDA also restricted Ketek to treat adults above 18 years-old for a lung bacterial infection called community acquired pneumonia (individuals who have not recently been hospitalized).

FDA Approval

Sanofi-Aventis, Ketek’s manufacturer, requested FDA approval for Ketek in 2001 and 2003. The FDA refused approval because there was insufficient evidence that Ketek was as safe and effective as other antibiotics in the market. In April 2004, the FDA approved Ketek to treat bacterial infections such as pneumonia, bronchitis, and sinusitis in the lungs and respiratory tract. Many experts criticized the FDA’s approval because the FDA received 54 reports (19 serious cases) warni ng it about liver damage in Ketek users in other countries.

January 2006 Public Health Advisory Warning

In January 2006, the FDA issued a Public Health Advisory warning Ketek users of an increased risk of severe and fatal liver damage. The warning was responsive to reports that linked Ketek to 23 severe liver damage cases, 12 liver failures, and 4 deaths.

FDA Suggests Adding Black Box Warning

In May 2006, a study published in Annals of Internal Medicine stated that Ketek use caused severe kidney damage to three patients in one hospital. One patient required a liver transplant and another patient died. This prompted the FDA to advise Sanofi-Aventis, Ketek’s manufacturer, to include a black box label warning detailing the increased liver damage risk.

New Black Box Warning

In February 2007, Sanofi-Aventis added the black box label warning about the increased risk of liver damage. Additionally, the black box label warning cautions against Ketek use by patients suffering from prior muscle weakness. The FDA also withdrew its approval of Ketek for treating bronchitis and sinusitis.

Clinical Trials Warning

In October 2007, the FDA sent Sanofi-Aventis, Ketek’s manufacturer, a warning letter regarding Ketek’s clinical trials. There is documented evidence that Sanofi-Aventis allegedly committed fraud during clinical trials in order to receive FDA approval. The fraud included forging documents and serious protocol violations. The warning letter stated that Sanofi-Aventis must correct the problems and fine the doctors that committed the fraud.

Information on Ketek Warnings

If you would like more information about Ketek warnings, please contact us today. If you or a loved one has been injured by Ketek, you may be entitled to compensation. Please contact our offices today to assess your legal rights.

Published November 17, 2011 by