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Severe Liver Injury after Treatment with the Leukotriene Receptor Antagonist Zafirlukast
- John F. Reinus, MD;
- Seth Persky, MD;
- Jill S. Burkiewicz, PharmD;
- David Quan, PharmD;
- Nathan M. Bass, MD, PhD; and
- Timothy J. Davern, MD
- From Albert Einstein College of Medicine, Bronx, New York; and University of California, San Francisco, San Francisco, California.
Abstract
Background: In registration trials, zafirlukast, an asthma medication, caused asymptomatic elevated aminotransferase levels in up to 5% of participants. Until now, however, no cases of severe hepatitis attributed to zafirlukast have been reported.
Objective: To report the clinical characteristics of three patients with severe hepatitis due to zafirlukast.
Design: Case report.
Setting: One community hospital and two university hospitals.
Patients: Three middle-aged women taking zafirlukast, 20 mg twice per day.
Intervention: Discontinuation of zafirlukast therapy in three patients, steroid therapy in two patients, and orthotopic liver transplantation in one patient.
Measurements: Serum aminotransferase and bilirubin levels, standard blood tests for causes of hepatitis other than drug toxicity, and liver biopsy in two patients.
Results: Patient 1 recovered spontaneously, had a severe relapse after inadvertent rechallenge with the medication, and ultimately made a complete recovery. Patient 2 developed subfulminant hepatic failure and required liver transplantation. Patient 3 developed severe hepatitis that improved after treatment with corticosteroids. Liver tissue was available from two patients and showed histologic changes commonly associated with drug reactions.
Conclusion: Patients receiving zafirlukast may develop severe liver injury and should be observed for signs and symptoms of hepatitis.
Article and Author Information
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An abstract describing patients 1 and 3 was presented as a poster at the annual meeting of the American College of Gastroenterology in 1999.
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Acknowledgments: The authors gratefully acknowledge the effort of the Acute Liver Failure Study Group (supported by grant R-O3 DK52827-01 from the National Institutes of Health [Principal Investigator, William M. Lee, MD]) for partial collection of data for patient 2.
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Requests for Single Reprints: John F. Reinus, MD, Division of Gastroenterology and Hepatology, Montefiore Medical Center, 111 East 210th Street, Bronx, NY 10467; e-mail, jreinus{at}montefiore.org.
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Current Author Addresses: Drs. Reinus and Persky: Division of Gastroenterology and Hepatology, Montefiore Medical Center, 111 East 210th Street, Bronx, NY 10467.
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Dr. Burkiewicz: Midwestern University, 555 West 31st Street, Downers Grove, IL 60515.
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Dr. Quan: University of California, San Francisco, 521 Parnassus Avenue, Box 0622, San Francisco, CA 94143.
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Drs. Bass and Davern: University of California, San Francisco, 503 Parnassus Avenue, San Francisco, CA 94143.
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Author Contributions: Conception and design: J.F. Reinus, S. Persky, N.M. Bass, T.J. Davern.
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Analysis and interpretation of the data: J.F. Reinus, S. Persky, J.S. Burkiewicz, N.M. Bass, T.J. Davern.
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Drafting of the article: J.F. Reinus, S. Persky, J.S. Burkiewicz, N.M. Bass, T.J. Davern.
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Critical revision of the article for important intellectual content: J.F. Reinus, S. Persky, N.M. Bass, T.J. Davern.
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Final approval of the article: J.F. Reinus, S. Persky, N.M. Bass, T.J. Davern.
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Provision of study materials or patients: J.F. Reinus, J.S. Burkiewicz, N.M. Bass, T.J. Davern.
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Administrative, technical, or logistic support: N.M. Bass, T.J. Davern.
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Collection and assembly of data: J.F. Reinus, J.S. Burkiewicz, N.M. Bass, T.J. Davern.
- Copyright ©2004 by the American College of Physicians
