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

21 March 2006 | Volume 144 Issue 6 | Pages 415-420

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 took 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.

Editors' Notes Context Telithromycin is the first ketolide antibacterial agent approved by the U.S. Food and Drug Administration. Physicians sometimes use it to treat common respiratory tract infections. Contribution This brief report describes 3 previously healthy patients who developed severe hepatotoxicity within a few days of taking telithromycin. One patient required orthotopic liver transplantation, and 1 died. Cautions The authors judged the cases as probably but not definitely related to telithromycin. Case reports cannot establish how often telithromycin-related severe hepatotoxicity occurs. Implications Telithromycin should be used cautiously pending further postmarketing surveillance data. —The Editors

 

Author and Article Information

From Carolinas Medical Center, Charlotte Gastroenterology and Hepatology, Carolinas HealthCare System, and Carolinas Pathology Group, Charlotte, North Carolina.

Grant Support: None.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Kimberly D. Clay, MD, Carolinas Medical Center, 1000 Blythe Boulevard, Charlotte, NC 28203; e-mail, kimberly.clay{at}carolinashealthcare.org.

Current Author Addresses: Drs. Clay, Pope, Rissmiller, Purdum, and Banks: Carolinas Medical Center, 1000 Blythe Boulevard, Charlotte, NC 28203.

Dr. Hanson: Charlotte Gastroenterology and Hepatology, 2015 Randolph Road 208, Charlotte, NC 28207.

Author Contributions: Conception and design: K.D. Clay, J.S. Hanson, S.D. Pope, R.W. Rissmiller.

Analysis and interpretation of the data: K.D. Clay, S.D. Pope, R.W. Rissmiller, P.P. Purdum.

Drafting of the article: K.D. Clay, J.S. Hanson, S.D. Pope, R.W. Rissmiller, P.P. Purdum, P.M. Banks.

Critical revision of the article for important intellectual content: K.D. Clay, J.S. Hanson, S.D. Pope, R.W. Rissmiller, P.P. Purdum.

Final approval of the article: K.D. Clay, J.S. Hanson, R.W. Rissmiller, P.P. Purdum.

Provision of study materials or patients: K.D. Clay, J.S. Hanson, R.W. Rissmiller, P.M. Banks.

Administrative, technical, or logistic support: K.D. Clay, S.D. Pope.

Collection and assembly of data: K.D. Clay, S.D. Pope.

Rapid Responses:

Read all Rapid Responses

Clarifications on case reports

Joseph S. Bertino

Annals Online, 21 Feb 2006 [Full text]

Re: Clarifications on case reports

Kimberly D. Clay

Annals Online, 15 Jun 2006 [Full text]