Ketek (Telithromycin) Linked to Two Cases of Liver Failure and Implicated in a Third Case of Hepatitis

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Ketek (Telithromycin) Linked to Two Cases of Liver Failure and Implicated in

a Third Case of Hepatitis PHILADELPHIA, PA -- January 20, 2006 -- Three case

reports of liver problems after taking the antibiotic telithromycin (Ketek®) are

reported in Annals of Internal Medicine today.

 

Researchers at Carolinas Medical Center in Charlotte, N.C., say that one of the

patients died; one required and received a liver transplant; and the third

recovered from drug-induced hepatitis after the antibiotic was stopped.

 

The article, " Severe Hepatotoxicity of Telithromycin: Three Case Reports and

Literature Review " will be published in the March 21, 2006, print edition of the

journal. It was released early today online.

 

" These cases could represent an unusual clustering of a rare, idiosyncratic drug

reaction at one medical center, " said John S. Hanson, MD, an author and

hepatologist with the liver transplant center at Carolinas Medical Center.

 

" However, the severity of liver injury in two of our patients warrants this

report in the medical literature and will alert other physicians to this

possible link with telithromycin. "

 

Dr. Hanson said that, despite the three reports, " At this point, there is not

enough data to indicate major changes in prescribing habits. "

 

All cases have been referred to the FDA's Adverse Event Reporting System.

 

Patients taking Ketek® should report symptoms such as malaise, weakness, or

jaundice to their prescribing physicians.

 

Telithromycin was approved by the U.S. Food and Drug Administration in 2004 to

treat acute bacterial infections from chronic bronchitis, acute bacterial

sinusitis and community-acquired pneumonia.

 

Telithromycin, an antibiotic derived from the macrolide class of antibacterial

agents, appears effective against some pneumonia strains resistant to other

older antibacterials such as penicillin.

 

In the three cases described in the Annals of Internal Medicine article, liver

problems were observed after the patients began taking telithromycin. The

reports do not prove that the antibiotic caused the liver impairment. But, in

the article, the authors advise " caution in prescribing this drug pending

further postmarketing surveillance data. "

 

Patients in two of the three cases reported some use of alcohol, although no

prior liver damage had been noted. Authors say that the relationship between

telithromycin and alcohol use " warrants further study. "

 

Carolinas Medical Center, an academic medical center teaching hospital, is a

861-bed facility of Carolinas HealthCare System. CHS is the largest healthcare

system in the Carolinas and the third largest public system in the nation.

 

 

SOURCE: American College of Physicians

 

 

 

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peace. "

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