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Drug Industry News

Ketek Antibiotic Risks: FDA warns

-January 24, 2006

According to the FDA, three people have suffered severe liver damage as a result of taking the antibiotic Ketek (telithromycin) . This antibiotic medication is commonly used to treat pneumonia, bronchitis, and sinus infections. The FDA states they are currently evaluating Ketek's safety to determine the frequency of liver problems associated with the drug, manufactured by Sanofi-Aventis.

Researchers have published a detailed report of the three cases of serious Ketek liver problems in the Annals of Internal Medicine .

All three of these seriously injured patients developed jaundice-yellowing of the skin and eyes-and abnormal blood tests indicated diminished liver function. Of these three Ketek liver damage patients, one recovered, one required a liver transplant, and other third died. Alcohol use was a factor in the two latter cases, which indicates a potentially increased risk of liver damage when alcohol and Ketek is used in combination.

All three Ketek liver damage patients had been in good health and were not taking any other medications when they began using Ketek.

While the FDA continues to investigate the risk of Ketek liver problems, the agency recommends that patients taking Ketek should seek immediate medical attention at the first sign of liver damage, such as blurry vision, jaundice and/or abnormal kidney function as indicated by a blood test. Patients currently using Ketek may wish to speak with their health care professional about the drug side effects associated with this medication.

For more information on Ketek and safety problems, please contact us to confer with an attorney.

 

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