An antibiotic approved by the FDA in 2004 is now under investigation by the agency after reports of severe liver damage in some patients taking the drug.
One death has already been linked to telithromycin, which is marketed as Ketek and manufactured by Sanofi Aventis Pharmaceuticals. Another patient needed a liver transplant and a third recovered from drug-induced hepatitis after discontinuing treatment with Ketek.
According to [Centre Watch Clinical Trials Listing Service], Ketek oral tablets contain telithromycin which kills many of the types of bacteria that can infect the lungs and sinuses, and has been found to treat these infections safely. The drug was designed to deliver targeted coverage in community-acquired upper and lower respiratory tract infections.
The FDA approved Ketek based on eight clinical trials involving 2,016 subjects. Ketek was approved for the following:
• community-acquired pneumonia
• acute sinusitis
• chronic bronchitis
The FDA said it would search its databases for other reports of liver problems in patients treated with the drug.
The known side effects are:
• Loose Stools
If you or you know anyone who has taken Ketek and has experienced any sort of liver problems, including jaundice, talk to your doctor immediately.
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Antibiotic Ketek may be linked to severe liver damage
|. By Jane Mundy|
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