FDA Orders Black Box Warning for Ketek
February 12, 2007
In May 2006, a study published in Annals of Internal Medicine stated that Ketek, a popular antibiotic drug, caused severe kidney damage to three patients in one hospital. One patient required a liver transplant and another patient died. This prompted the U. S. Food and Drug Administration (FDA) to advise Sanofi-Aventis, Ketek’s manufacturer, to include a black box warning on Ketek’s label detailing the increased liver damage risk.
Sanofi-Aventis added the black box warning about the increased risk of liver damage to Ketek’s label in February 2007. In addition to the increased risk of liver damage, the black box warning cautions against Ketek use by patients suffering from prior muscle weakness. The FDA also restricted Ketek’s approved uses. Now, Ketek is only FDA approved to treat adults above 18 years-old for a lung bacterial infection called community acquired pneumonia (pneumonia in individuals who have not recently been hospitalized).
Sanofi-Aventis requested FDA approval for Ketek in 2001 and 2003. Both times, the FDA refused to approve Ketek because there was insufficient evidence that Ketek was as safe and effective as other antibiotics on the market. Finally, in April 2004, the FDA approved Ketek to treat bacterial infections in the lungs and respiratory tract, such as pneumonia, bronchitis, and sinusitis. Many experts criticized the FDA for approving Ketek because the FDA had received 54 reports (19 serious cases) warning it about liver damage in Ketek users in other countries.
After Ketek was released on the market, the FDA received reports that linked Ketek to 23 cases of severe side effects, including 12 liver failures and 4 deaths. In response to these reports, the FDA issued a Public Health Advisory notifying Ketek users of an increased risk of severe and fatal liver damage. After completing a safety assessment of Ketek, the FDA eventually ordered the black box warning and restricted Ketek’s approved uses.
In October 2007, the FDA sent Sanofi-Aventis 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.
If you or a loved one has been injured by Ketek, you may be entitled to compensation. Please contact us today for a confidential and free assessment of your legal rights.