ABSTRACT
Adverse drug reactions affecting the liver represent an important challenge for safety
in drug development. Drugs can reproduce practically the whole spectrum of liver diseases,
but acute hepatitis is the most common syndrome. Drug hepatotoxicity is one of the
most common causes of fulminant hepatitis. Most hepatic drug reactions occur in only
a small proportion of individuals, making them difficult to detect at the time of
drug development. Liver injury is principally recognized on the basis of spontaneous
reports within the first 2 years of marketing a new drug. The prevalence of drug hepatotoxicity
is poorly documented by a small number of retrospective studies. Despite the development
of international analytical methods to allow standardized evaluation, the diagnosis
remains indeterminate in many cases. Acquired and genetic factors influence the individual
susceptibility to drug hepatotoxicity. Important directions for the future include
prospective studies of the incidence of hepatic adverse drug reactions, finding specific
markers that augment or replace causality assessment, and further elucidating the
role of the genetic and environmental factors that contribute to individual susceptibility.
KEYWORDS
Adverse drug reactions - liver - drug hepatotoxicity - drug safety - epidemiology
- hepatitis - individual susceptibility pharmacogenetics
