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Ketek
Ketek® (telithromycin) is an antibiotic prescription drug used for the treatment mild-to-moderate respiratory infections like pneumonia, chronic bronchitis and acute bacterial sinusitis. Ketek is manufactured by Sanofi-Aventis, a French company.
Apparently, Ketek may cause jaundice, hepatitis, cirrhosis, and serious liver injury, liver failure and even death. Beyond the possibility of liver damage, Ketek may also be associated with blurred vision and loss of consciousness, and, in patients with myasthenia gravis, a rare neurological disorder, it may cause death.
U.S. Congressional Hearings
In February 2008, The House Energy and Commerce Oversight and Investigations Subcommittee conducted hearings into whether Sanofi-aventis problems in clinical trial data it submitted to the FDA and whether the FDA conspired with the drug maker to approve Ketek.
U.S. FDA Action
The FDA approved Ketek April 2004. In mid 2006, the FDA warned that Ketek could in rare circumstances cause serious liver injury, liver failure and even death and strengthened the warnings in connection with myasthenia gravis.
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