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Labetalol Hepatotoxicity

John A. Clark, MD, MSPH; Hyman J. Zimmerman, MD; and Lelia Ann Tanner, RPh
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Requests for Reprints: L. Ann Tanner, RPh, Food and Drug Administration, Office of Epidemiology and Biostatistics, HFD-735, 5600 Fishers Lane, Rockville, MD 20857.

Current Author Addresses: Dr. Clark: Drug Experience and Epidemiology (BLA-31), Merck, Sharp, and Dohme Research Laboratories, West Point, PA 19486.

Ms. Tanner: Food and Drug Administration, Office of Epidemiology and Biostatistics, HFD-735, 5600 Fishers Lane, Rockville, MD 20857.

Dr. Zimmerman: Hepatic Pathology Department, Room 3107, Armed Forces Institute of Pathology, Washington, DC 20306-6000.

Ann Intern Med. 1990;113(3):210-213. doi:10.7326/0003-4819-113-3-210
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The Food and Drug Administration has received 11 reports of cases (three fatal) in the United States in which hepatocellular damage was associated with labetalol. The temporal circumstances strongly implicate labetalol; the conditions of nine patients improved after cessation of labetalol therapy, and one patient had a recurrence after therapy was restarted. Follow-up with each reporting physician failed to provide historic or laboratory evidence for other viral, toxic, or drug-induced causes of hepatocellular damage, and the case series did not show the demographic and historic risk factors that would be expected if non-A, non-B hepatitis were the cause. Reports of microscopic liver examinations were available in the 5 cases in which they were done. The reported histologic changes were consistent with hepatocellular necrosis in four instances and chronic active hepatitis in one. The clinical presentation of the cases was most compatible with the mechanism of metabolic idiosyncracy, but other pathogenetic explanations could not be entirely excluded.


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