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Brief communication: severe hepatotoxicity of telithromycin: three case reports and literature review
Kimberly D Clay1, John S Hanson, Scott D Pope
1Carolinas Medical Center, Charlotte Gastroenterology and Hepatology, Carolinas HealthCare System, and Carolinas Pathology Group, Charlotte, North Carolina 28203, USA. kimberly.clay@carolinashealthcare.org
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.
Insights
Telithromycin, a ketolide antibiotic, can cause severe liver damage (hepatotoxicity). This case series highlights three instances of acute hepatitis, with one fatality and one requiring liver transplantation, emphasizing the need for caution.
Area of Science:
- Pharmacology
- Hepatology
- Infectious Diseases
Background:
- Telithromycin is a U.S. Food and Drug Administration-approved ketolide antibiotic.
- It is indicated for acute bacterial infections including sinusitis, bronchitis, and community-acquired pneumonia.
Observation:
- Three previously healthy patients developed severe hepatotoxicity after taking telithromycin.
- Patients presented with acute hepatitis, jaundice, and abnormal liver function tests within days of use.
- Viral serology was negative in all cases.
Findings:
- One patient recovered spontaneously, one died, and one required orthotopic liver transplantation.
- Histologic examination revealed massive hepatic necrosis in two patients.
- Two patients reported some history of alcohol use.
Implications:
- Telithromycin can cause severe, potentially fatal, hepatotoxicity.
- Prescribing telithromycin warrants caution due to the risk of severe liver injury.
- Further postmarketing surveillance is crucial to establish the frequency of telithromycin-related hepatotoxicity.
Related Concept Videos
Therapeutic Drug Monitoring: Affecting Factors
Effect of Hepatic Disease on Pharmacokinetics: Drug Dosing and Hepatic Blood Flow
Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test
Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment
Drug Toxicity: Overview
Drug Toxicity: Risk factors

