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Hy's Law is the rule that a patient is at high risk for severe drug-induced liver injury (DILI) if given a drug that causes hepatocellular (not cholestatic) injury with jaundice. This law is based on observations by Hy Zimmerman, a leading scholar of drug induced liver injury. Some people suggest that principle is called a hypothesis or observation.
The Hy Law Case has three components:
- These drugs cause hepatocellular injury, generally defined as high ALT or AST by 3-fold or greater above the normal upper limit. Often with a much larger aminotransferase (5-10x) upper limit of normal.
- Among the subjects showing elevated aminotransferase, they also experienced an increase in their total serum bilirubin greater than 2ÃÆ'â € "the normal upper limit, without the findings of cholestasis (defined as serum alkaline phosphatase activity less than 2ÃÆ'â €" normal upper limit).
- No other reason can be found to explain a combination of elevated aminotransferase and total serum bilirubin, such as viral hepatitis, alcohol abuse, ischemia, pre-existing liver disease, or other drugs capable of causing the injury to be observed.
In Zimmerman's analysis of 116 patients with hepatocellular and jaundice injury due to exposure to the drug, 76% continued to require liver or death transplantation. Other studies have reported lower mortality but still significant at 10%.
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Source of the article : Wikipedia
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