Hy's law

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Overview

Hy's law is defined as drug-induced liver injury (DILI) leading to jaundice. The law is based on observations by Hy Zimmerman, a major scholar of drug-induced liver injury.

Definition

Hy’s Law cases have the following three components (http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0396-gdl0001.pdf):

1. The drug causes hepatocellular injury, generally shown by more frequent 3-fold or greater elevations above the ULN of ALT or AST than the (nonhepatotoxic) control agent or placebo.
2. Among subjects showing such AT elevations, often with ATs much greater than 3xULN, some subjects also show elevation of serum TBL to >2xULN, without initial findings of cholestasis (serum alkaline phosphatase (ALP) activity >2xULN).
3. No other reason can be found to explain the combination of increased AT and TBL, such as viral hepatitis A, B, or C, preexisting or acute liver disease, or another drug capable of causing the observed injury.

Prognosis

Without a hepatic transplant, patients meeting criteria for Hy's Law face a case fatality rate of 10% to 50%.