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KETEK LINKED TO LIVER FAILURE
by Jane Mundy
Ketek is an antibiotic used to treat respiratory infections such as pneumonia, chronic bronchitis, and acute bacterial sinusitis and it is also used to treat some infections that are resistant to other drugs. It also comes with a black box warning stating that Ketek may cause fatal liver damage.
By May 2006, the FDA had reports that 12 Ketek patients had suffered acute liver failure, two of whom had died and one required a liver transplant. In addition, 23 more patients had serious liver injuries and 44 patients with less severe liver problems. Finally, Sanofi-Aventis was required to upgrade Ketek with a black box warning in mid May, 2006. A black box warning, printed in bold type and outlined in a black box, is the FDA's strongest form of safety advisory.
The FDA recommended that the warning state "severe, life-threatening, and in some cases fatal" liver toxicity has been reported in patients taking Ketek (telithromycin)." As well, Ketek cannot be sold to treat sinusitis and bronchitis even though it had previously been approved for such uses. But it can continue to sell Ketek for pneumonia with the new warning.
The FDA has been criticized by lawmakers and former FDA employees for approving Ketek after some initial studies indicated the drug could be dangerous. In a recent interview to a congressional hearing in Washington, former FDA scientist David Ross said that FDA supervisors forced him to retract a finding that Ketek was probably too dangerous to be approved for bronchitis and sinusitis.
Launched in 2004 by Sanofi-Aventis, about 28 million people have been treated with the orange tablets in more than 50 countries. The drug manufacturer reported US sales alone of Ketek at $58 in the nine months ended Sept.30, 2006.
It remains to be seen whether this drug should stay on the market.
Ketek Side Effects
Known side effects of Ketek include liver damage, jaundice, drowsiness, dizziness, blurred vision or double vision, and nausea.
If you or someone you know has taken Ketek and developed any of the above symptoms, contact a doctor immediately. You should also consider contacting a Ketek attorney who will review your case at no charge.
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