Amoxicillin-clavulanate potassium-associated cholestasis

K. Rajender Reddy, Patrick Brillant, Eugene R Schiff

Research output: Contribution to journalArticle

82 Citations (Scopus)

Abstract

Amoxicillin-clavulanate potassium, a semisynthetic penicillin-β-lactamase inhibitor combination drug, is a widely used oral antibiotic. Since the marketing of this drug in 1984, more than nine million prescriptions have been dispensed. Several cases of jaundice and hepatic dysfunction have been observed and reported to the Food and Drug Administration and the pharmaceutical company (Beecham Laboratories). A review of 18 of these cases revealed a predominately cholestatic syndrome in 7 cases, a mixed hepatocellular-cholestatic picture in 6 cases, a hepatocellular pattern in 4, and in 1 case the injury could not be clearly defined. No fatalities were observed, and all cases had reversal of hepatic dysfunction upon cessation of the drug. Fever was present in 2 patients and eosinophilia in 6 of 10 patients tested, suggesting a hypersensitivity phenomenon contributing to hepatic dysfunction in some of the cases. A percutaneous liver biopsy had been performed in 7 of 18 patients and four of these were reviewed by the authors. Prominent centrizonal cholestasis was seen in all four biopsies. Additionally, 1 patient had periportal and another had midzonal cholestasis. Although infrequent, recognition of an often benign cholestatic syndrome associated with amoxicillin-clavulanate potassium will help avoid unnecessary, invasive, and expensive diagnostic studies and also ameliorate symptoms upon withdrawal of the drug.

Original languageEnglish
Pages (from-to)1135-1141
Number of pages7
JournalGastroenterology
Volume96
Issue number4
StatePublished - Jan 1 1989

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Clavulanic Acid
Cholestasis
Amoxicillin
Liver
Pharmaceutical Preparations
Biopsy
Substance Withdrawal Syndrome
Eosinophilia
Drug Combinations
United States Food and Drug Administration
Jaundice
Marketing
Penicillins
Prescriptions
Hypersensitivity
Fever
Anti-Bacterial Agents
Wounds and Injuries

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Amoxicillin-clavulanate potassium-associated cholestasis. / Reddy, K. Rajender; Brillant, Patrick; Schiff, Eugene R.

In: Gastroenterology, Vol. 96, No. 4, 01.01.1989, p. 1135-1141.

Research output: Contribution to journalArticle

Reddy, KR, Brillant, P & Schiff, ER 1989, 'Amoxicillin-clavulanate potassium-associated cholestasis', Gastroenterology, vol. 96, no. 4, pp. 1135-1141.
Reddy, K. Rajender ; Brillant, Patrick ; Schiff, Eugene R. / Amoxicillin-clavulanate potassium-associated cholestasis. In: Gastroenterology. 1989 ; Vol. 96, No. 4. pp. 1135-1141.
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