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Appendix 4

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TABLE A4–1: An Approach to Evaluating a Suspected Hepatotoxic Reaction
Points –3 –1 0 +1 +2 +3
What is the temporal relationship? (days)
From the start of therapy ?? <5 >90 5–90
From the end of therapy >30 ?? <30
Is there evidence of the concurrent use of a hepatotoxina? Yes Maybe ?? No
Is there an alternate cause, such as viral hepatitis? Yes Most likely—Yes ?? Most likely—No   No
Are there extrahepatic signs or symptoms?
Dermatologic: rash, palmar erythema, cutaneous vasculitis No Yes (+1 for each)
Dermatologic: spider nevi, white nails (aka Terry’s nails) No Yes (+1 for each)
Hematologic: coagulation disorders No Yes (+1 for each)
Endocrine: insulin resistance, thyroid dysfunction No Yes (+1 for each)
Endocrine: adrenal insufficiency, hypogonadism No Yes (+1 for each)
Skeletal muscular: arthralgias, arthritis No Yes (+1 for each)
Neurologic: encephalopathy No Yes (+1 for each)
Portopulmonary hypertension No Yes (+1 for each)
Does the literature support a connection with this drug?
Listed in the product labeling Yes
Published reports in the literature Yes
No information available, reaction is undocumented Yes
Results from a rechallenge with the drug Negative Inconclusive Positive

(??, Uncertain.)

A total score <7 makes it unlikely that this is a hepatotoxic reaction.

As the score approaches 14; the possibility that this is a hepatotoxic reaction increases toward certainty.

a

Drug, herbal remedy, or other occupational exposure known to be potentially hepatotoxic.

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TABLE A4–2: Environmental Hepatotoxins and Associated Occupations at Risk for Exposure
Hepatotoxin Associated Occupations at Risk for Exposure
Arsenic Chemical plant, agricultural workers
Carbon tetrachloride Chemical plant workers, laboratory technicians
Copper Plumbers, sculpture artists, foundry workers
Dimethylformamide Chemical plant workers, laboratory technicians
2,4-Dichlorophenoxyacetic acid Horticulturists
Fluorine Chemical plant workers, laboratory technicians
Toluene Chemical plant, agricultural workers, laboratory tech
Trichloroethylene Printers, dye workers, cleaners, laboratory technicians
Vinyl chloride Plastics plant workers; also found as a river pollutant

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TABLE A4–3: Relative Patterns of Hepatic Enzyme Elevation in Liver Injury. R = (Measured ALT/Upper Normal Limit of ALT) ÷ (Measured Alk Phos/Upper Normal Limit of Alk Phos)
Enzyme   Hepatocellular Cholestatic Mixed Injury Chronic
R-Values   5 2 3–4
Alkaline phosphatase Alk Phos ↑↑↑ ↑↑↑
5′-Nucleotidase 5-NC, 5NC ↑↑↑ ↑↑↑
γ-Glutamyltransferase GGT, GGTP ↑↑↑ ↑↑↑ ↑↑
Aspartate aminotransferase AST ↑↑↑ ↑↑↑ ↑↑
Alanine aminotransferase ALT ↑↑↑ ↑↑↑ ↑↑
Lactate dehydrogenase LDH ↑↑↑ ↑↑↑

(↑, <100% of normal; ↑↑, >100% of normal; ↑↑↑, >300% of normal.)

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