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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.

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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].

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Isoflurane

Last Update: January 1, 2018.

OVERVIEW

Introduction

Isoflurane is a commonly used inhalational anesthetic and has an excellent safety record. Isoflurane has been linked to rare instances of severe acute liver injury resembling halothane induced liver injury in small case series and individual case reports.

Background

Isoflurane (eye" soe flur' ane) is a widely used major anesthetic agent with rapid onset of action and rapid dispersal. Isoflurane is a halogenated anesthetic, similar in structure and activity to halothane, desflurane, enflurane and sevofurane. Isoflurane is typically given in inhaled concentrations of 0.5% to 3% in oxygen. Because of its pungent odor and somewhat slow onset of action, isoflurane is typically used to maintain anesthesia after induction with other agents such as nitrous oxide, fentanyl and propofol. Isoflurane became available for use in the United States in 1979. Isoflurane must be administered in a controlled situation by a properly trained anesthesiologist or nurse anesthetist.

Hepatotoxicity

Prospective, serial blood testing often demonstrates minor transient elevations in serum aminotransferase levels in the 1 to 2 weeks after major surgery and halogenated anesthetic agents. Appearance of ALT levels above 10 times the upper limit of normal, however, is distinctly unusual and points to significant hepatotoxicity. Clinically apparent, severe hepatic injury from isoflurane is very rare, only isolated case reports and small case series having been published. The injury is marked by acute elevations in serum aminotransferase levels (5- to 50-fold) and appearance of jaundice within 2 to 21 days of surgery. There are usually minimal increases in alkaline phosphatase and gammaglutamyl transpeptidase levels. Jaundice is usually preceded by a day or two of fever and may be accompanied by rash and eosinophilia. The acute liver injury may be self-limited and resolve within 4 to 8 weeks, but can be severe and associated with acute liver failure. A strong risk factor is previous exposure to any of the halogenated anesthetics and particularly a history of halothane hepatitis or unexplained fever and rash after anesthesia with one of these agents. The differential diagnosis of acute liver injury after surgery and anesthesia is sometimes difficult, and a clinical picture similar to isoflurane hepatitis can be caused by shock or ischemia, other idiosyncratic forms of drug induced liver injury and acute viral or herpes hepatitis.

Likelihood score: B (highly likely cause of clinically apparent liver injury).

Mechanism of Injury

The mechanism of isoflurane hepatotoxicity is suspected to be similar to that of halothane and associated with creation of reactive intermediates. Isoflurane is metabolized to some extent by the microsomal drug metabolizing enzyme CYP 2E1 to a trifluoroacetylated reactive intermediate (TFA) that is capable of binding to multiple intracytoplasmic proteins forming potentially immunogenic adducts. The TFA adducts induce antibodies that can be detected in patients with isoflurane, desflurane as well as halothane hepatotoxicity and are also found in a proportion of health care workers exposed to the volatile anesthetics.

Outcome and Management

Severity ranges from mild and transient aminotransferase elevations without symptoms or other evidence of liver injury, to a self limited symptomatic acute hepatitis-like reaction to severe, acute hepatic failure. The severity and prognosis may relate in part of patient age, being more severe in the elderly and both milder and less common in children. Obesity may also be both a predisposing factor and predictor of outcome. Chronic liver injury from isoflurane exposure has not been described. Patients with isoflurane induced hepatitis should be cautioned against future exposure to fluorinated hydrocarbon anesthetics such as halothane, enflurane, desflurane or sevoflurane.

Drug Class: Halogenated Anesthetics

Other drugs in the Class: Desflurane, Enflurane, Halothane, Sevoflurane

CASE REPORT

Case 1. Isoflurane hepatotoxicity in a patient with previous history of halothane-induced hepatitis.

[Modified from: Hasan F. Isoflurane hepatotoxicity in a patient with a previous history of halothane-induced hepatitis. Hepatogastroenterology 1998; 45: 518-22. PubMed Citation]

A 35 year old woman with diabetes and a previous history of elevated ALT levels after halothane exposure underwent arthroscopy under general anesthesia with isoflurane. Her perioperative and postoperative liver profile was normal. Two weeks later, she presented with jaundice. Of interest, she had a history of halothane induced liver injury 1 and 7 years previously, both episodes associated with jaundice and marked serum aminotransferase elevations. On physical examination she was jaundiced and had mild hepatomegaly. Laboratory examination revealed total bilirubin 27.2 mg/dL, ALT 1950 U/L, alkaline phosphatase 226 U/L, albumin 3.5 g/dL, total protein 7.5 g/dL, and prothrombin time 16 sec (normal 11 sec). Complete blood counts were normal. Abdominal ultrasound showed hepatomegaly with increased echogenicity throughout the liver. The gallbladder, common bile duct, spleen and portal veins were normal. Tests for acute hepatitis A, B and C were negative as were autoantibodies. Liver biopsy showed severe, predominantly centrozonal necrosis and cell loss with diffuse inflammatory infiltrates. The patient was treated with supportive measures and the liver function tests improved spontaneously. She was discharged after 16 days of hospitalization and recovered after 12 weeks. Subsequently, she underwent abscess drainage under propofol anesthesia without incident.

Key Points

Medication:Isoflurane
Pattern:Hepatocellular (R=25.5)
Severity:3+ (jaundice, hospitalization)
Latency:1 to 2 weeks
Recovery:3 months
Other medications:Indomethacin, insulin

Laboratory Values

DayALT
(U/L)		Alk P
(U/L)		Bilirubin
(mg/dL)		Other
Feb 18, 1987Received halothane
Mar 03, 198714101447.6Jaundice
Aug 12, 1993Received halothane
Aug 24, 1993183018310.5Jaundice, itching
Sep 17, 1994Received isoflurane
Sep 23, 1994195022627.1Jaundice, liver biopsy
Normal Values <45 <130 <1.2

* Converted from micromoles to mg/dL.

Comment

Severe isoflurane hepatotoxicity is rare. Most commonly the injury presents with fever and jaundice 3 to 14 days after surgery. Many affected patients have a history of previous halothane or isoflurane exposure. Female gender, as in this patient, is a risk factor. The latency period of halothane anesthetic induced liver dysfunction decreases with the frequency of exposure. Rash occurs in 10% of patients. This is a diagnosis of exclusion, and the most common causes of jaundice postoperatively that require exclusion are sepsis, biliary disease, parenteral nutrition related jaundice and shock or ischemia. Recovery is expected after 3 to 4 months. Rechallenge should be avoided, using total intravenous anesthetic technique whenever possible, which this patient later underwent without difficulty.

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Isoflurane – Generic, Forane®

DRUG CLASS

Anesthetics, Halogenated

COMPLETE LABELING

Product labeling at DailyMed, National Library of Medicine, NIH

CHEMICAL FORMULA AND STRUCTURE

DRUGCAS REGISTRY NOMOLECULAR FORMULASTRUCTURE
Isoflurane 26675-46-7 C3-H2-Cl-F5-O
Isoflurane chemical structure

ANNOTATED BIBLIOGRAPHY

References updated: 01 January 2018

  • Zimmerman HJ. Anesthetic agents. In, Zimmerman, HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999: pp. 457-82.
    (Expert review of hepatotoxicity of anesthetic agents published in 1999; mentions that the newer halogenated anesthetics appear to be safer than halothane, but that hints of liver injury from desflurane and sevoflurane have appeared).
  • Kenna JG. Mechanism, pathology, and clinical presentation of hepatoxicity of anesthetic agents. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013: pp 403-22.
    (Review of liver injury from anesthetic agents published in 2013; mentions that a few cases of postoperative liver injury have occurred in patients exposed to isoflurane).
  • Patel PM, Patel HH, Roth DM. General anesthetics and therapeutic gases. In, Brunton LL, Chabner KA, Knollman KC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 12th ed. New York: McGraw-Hill, 2011, pp. 527-64.
    (Textbook of pharmacology and therapeutics; isoflurane is a commonly used inhalation anesthetic; 99% is excreted unchanged by the lungs and only 0.2% is metabolized by CYP 2E1).
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    (65 year old woman was found to have liver test abnormalities 11 days after surgery and isoflurane anesthesia [bilirubin 0.4 mg/dL, ALT 229 U/L, Alk P 900 U/L] which was initially attributed isoflurane, but later shown to be due to biliary obstruction).
  • Lambert DH. Isoflurane and hepatic dysfunction. Anesth Analg 1985; 64: 458-60. [PubMed: 2858992]
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    (33 year old man developed fatigue, fever and jaundice 6 to 8 days after surgery and isoflurane anesthesia [bilirubin ~4 mg/dL, ALT 2500 U/L, Alk P 190 U/L] with recovery in two months; also received Factor IX IV, raising possibility of short incubation period “non-A, non-B hepatitis”).
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    (Letter in response to Grégoire [1986] contesting conclusions).
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    (44 year old woman developed acute liver injury starting 2 days after surgery and isoflurane anesthesia [bilirubin 9.6 mg/dL, AST >2000 U/L, LDH >4000 U/L], progressing to death by day 4; no rash, fever or eosinophilia and liver injury possibly due to ischemia).
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    (Human microsomes were used to assess metabolism of sevoflurane: CYP 2E1 was the major if not sole enzyme catalyzing defluorination of sevoflurane and others).
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    (45 year old woman developed ALT elevations starting 3 days after isoflurane anesthesia [peak bilirubin 2.5 mg/dL, ALT 320 U/L, Alk P 900 U/L], with recurrence on reexposure to isoflurane [bilirubin 0.5 mg/dL, ALT 90 U/L, Alk P 400 U/L], resolving rapidly).
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    (37 year old man with 2 previous exposures to isoflurane developed serum enzyme elevations starting 7 days after halothane anesthesia [peak bilirubin 1.3 mg/dL, ALT 926 U/L, Alk P 472 U/L], resolving within 2 months).
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    (47 year old severely obese man with a history of halothane hepatitis developed fever 1 day and jaundice 10 days after surgery under isoflurane anesthesia [bilirubin 1.4 rising to 5.5 mg/dL, ALT 1576 U/L, 4% eosinophils], resolving within 40 days; also had anti-TFA-protein antibodies during the acute episode).
  • Gelven PL, Cina SJ, Lee JD, Nichols CA. Massive hepatic necrosis and death following repeated isoflurane exposure: case report and review of the literature. Am J Forensic Med Pathol 1996; 17: 61-4. [PubMed: 8838473]
    (30 year old woman had outpatient surgery under isoflurane anesthesia and died unexpectedly 2 days later, autopsy showed fat, inflammation and massive necrosis; role for isoflurane difficult to assess).
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    (67 year old man developed marked ALT elevations [>1000 U/L] starting 12 days after isoflurane anesthesia without symptoms, fever or jaundice and with rapid recovery; also had late appearance of anti-TFA antibodies).
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    (36 year old woman developed nausea, abdominal pain and fever 2 days after surgery using isoflurane anesthesia [bilirubin 4.8 mg/dL, ALT 1000 U/L, INR 2.1], ultimately undergoing liver transplantation but dying by day 12; anti-TFA negative, massive centrolobular necrosis in explant suggestive of ischemia).
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    (35 year old woman developed hepatitis 2 weeks after isoflurane anesthesia, having had 2 previous episodes of jaundice after halothane [peak bilirubin 27.4 mg/dL, ALT 1950 U/L, Alk P 226 U/L], resolving within 12 weeks. Case 1).
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    (Prospective analysis of ALT, AST, Alk P and bilirubin 1,2,3,7 and 14 days after sevo- or isoflurane [n=45 each] showed minimal increases in ALT and AST peaking at 7 days; elevated in ~15%, no patient was symptomatic or jaundiced).
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  • Lin J, Moore D, Hockey B, Di Lernia R, Gorelik A, Liew D, Nicoll A. Drug-induced hepatotoxicity: incidence of abnormal liver function tests consistent with volatile anaesthetic hepatitis in trauma patients. Liver Int 2014; 34: 576-82. [PubMed: 23944929]
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  • Hernández N, Bessone F, Sánchez A, di Pace M, Brahm J, Zapata R, A Chirino R, et al. Profile of idiosyncratic drug induced liver injury in Latin America. An analysis of published reports. Ann Hepatol 2014; 13: 231-9. (Systematic review of literature of drug induced liver injury in Latin American countries published from 1996 to 2012 identified 176 cases of which 5 [3%] were attributed to halothane and caused acute liver failure, while. [PubMed: 24552865]
    no other volatile anesthetic was listed).
  • Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al.; United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. Gastroenterology 2015; 148: 1340-52.e7. [PMC free article: PMC4446235] [PubMed: 25754159]
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