ABSTRACT
Adverse drug reactions affecting the liver represent an important challenge for physicians,
health authorities, and pharmaceutical companies. A recent prospective inquiry performed in a
liver and gastrointestinal unit revealed that 9% of admission was related to drug-induced
adverse effects, liver toxicity representing the major problem (1). Despite improvements in
toxicological studies and in the safety analysis of clinical trials, the early detection of drug
hepatotoxicity remains very difficult. This view is reinforced by the fact that the overall
frequency of hepatotoxicity for all drugs has not decreased in the last 10 years (2). Practically,
all cells present in the liver can be affected by drugs (1,3-6). The types of lesions may also vary
in their clinicopathological manifestations, according to the mechanism of hepatotoxicity, the
drug itself, details of the treatment course (low or high dose and duration of treatment), and the
susceptibility of the person taking the agent. This explains how drug hepatotoxicity can
reproduce a wide range of “natural” (non-iatrogenic) liver diseases (3-6). Acute hepatitis is
the most common syndrome. Acute liver failure is the most severe expression and represents
the major cause of fatalities related to drugs (7,8). As a consequence, it is also the major cause of
drug withdrawal from the pharmaceutical market.
