KETEK INFECTION AND DEATHS. Annals Of Internal Medicine

[RandyW]

Brief Communication: Severe Hepatotoxicity of Telithromycin: Three Case Reports and Literature Review

Kimberly D. Clay, MD, MPH; John S. Hanson, MD; Scott D. Pope, PharmD; Richard W. Rissmiller, MD; Preston P. Purdum III, MD; and Peter M. Banks, MD

21 March 2006 | Volume 144 Issue 6 |

Background: Telithromycin is a ketolide antibiotic approved by the U.S. Food and Drug Administration for acute bacterial infections causing sinusitis, bronchitis, and community-acquired pneumonia.

Objective: To describe 3 cases of severe hepatotoxicity in patients receiving telithromycin.

Design: Case reports.

Setting: A tertiary care medical center.

Patients: 3 previously healthy patients who had recently taken telithromycin and no other prescription medications.

Measurements: Serologic, histologic, and liver function tests.

Results: Within a few days of receiving telithromycin, the patients presented with acute hepatitis. All had jaundice and markedly abnormal results on liver function tests. Results of viral serologic tests were negative. One patient spontaneously recovered, 1 required orthotopic liver transplantation, and 1 died. Histologic examination in the latter 2 patients showed massive hepatic necrosis.

Limitations: Two patients had some history of alcohol use. The frequency of severe telithromycin-related hepatotoxicity cannot be established with case reports.

Conclusions: Telithromycin can cause severe hepatotoxicity. Caution is advised in prescribing this drug pending additional postmarketing surveillance data.

Telithromycin is the first ketolide antibacterial agent approved by the U.S. Food and Drug Administration (FDA). Derived from the macrolide class of antibacterial agents, telithromycin is approved for use in respiratory tract infections, including pneumonia, sinusitis, and bacterial exacerbations of chronic bronchitis (1). Ketolides are semisynthetic derivatives of the macrolides, with side-chain modifications on the 14-membered ring structure. These alterations substantially affect the molecule’s acid stability and create the ability to overcome most types of macrolide resistance (2). More than 30% of a telithromycin dose is metabolized by the liver; 50% is mediated by cytochrome P450 3A4, and 50% is cytochrome P450–independent (1). Approximately 20% of the dose is excreted unchanged in the bile, intestines, and urine (1).

We present 3 cases of drug-induced hepatotoxicity thought to be secondary to telithromycin. One case required liver transplantation, and 1 resulted in death. Each patient received medical care from at least 1 of the authors. Two of the 3 patients were hospitalized at Carolinas Medical Center in Charlotte, North Carolina, during the course of their treatment after taking telithromycin. All 3 cases have been reported to the FDA

Plesase Check this out for your Onc. Could be a major factor I Am. Deb was on this medicine.

[Fay A.]

Thank you for sharing this information with us. So many of the drugs we take as cancer patients are Liver toxic. After reading this I thought that if someone took just a plain Acetomenaphine along with this antibiotic it could be enough to do significant damage to the Liver.

Again, Thank you for thinking of us at this difficult time. You've just lost your wife and you continue to try to help others. It means a lot, and who knows who you might have helped by doing so.

[karen335]

I also as Fay said, THANK YOU, THANK YOU. You are a very strong person for continuing trying to help others....

Your angel Deb is smling down on you . She is so proud of you...

God Bless and prayers,

Karen

[RandyW]

Deb was on Ketek!! I have issues but do not want to go there right now.