Description

The liver by virtue of its unique location
between the intestine and the systemic circulation
plays an important role in metabolising foreign
substances (xenobiotics). It helps in detoxifying
absorbed substances; this in itself makes the liver a
common target for absorbed toxins and drugs.
During drug development, liver is the commonest
organ affected by toxicity; drug-induced liver injury
(DILI) is an important reason for failure of approval
of a new medication. As drug trials involving few
thousand participants are still likely to be
underpowered to identify rare, but serious adverse
reactions, these only become evident on use in large
numbers of patients post release.1 Recently,
troglitazone (an insulin sensitiser) was withdrawn
from the market following reports of about 100 cases
of liver failure or transplantation secondary to severe
liver injury.2 In 2006, Ximelagatran (Exanta) a
promising anticoagulant had to be prematurely
withdrawn due to reports of hepatotoxicity.