V. Previous report in the literature of cases of hepatotoxicity associated with the drug

No (drugs marketed for up to 5 years) No (drugs marketed for more than 5 years)

Table 37.3. Description of Clinical Diagnostic Scale (Maria & Victorino scale) (Maria and Victorino, 1997).

Component elements Scores

I. Temporal Relationship between drug intake and the reaction

A. Time from Drug intake until the onset of first clinical or laboratory manifestations 4 days to 8 weeks (or less than 4 days in cases of re-exposure

Less than 4 days or more than 8 weeks

B. Time from withdrawal of the drug until the onset of manifestations 0 to 7 days

8 to 15 days

More than 15 days (except in cases of prolonged persistence of the drug in the body after withdrawal; e.g. Amiodarone)

C. Time from withdrawal of the drug until normalisation of laboratory values (Decrease to values 2x the upper limit of normal values)

Less than 6 months (cholestatic or mixed pattern) or 2 months (hepatocellular) More than 6 months (cholestatic or mixed pattern) or 2 months (hepatocellular)

II. Exclusion of alternative causes (viral hepatitis, alcoholic liver disease, biliary obstruction, pre-existing liver disease, ischaemic hepatitis)

Complete exclusion Partial exclusion

Possible alternative cause detected Probable alternative cause detected

III. Extrahepatic manifestations (rash, fever, arthralgia, eosinophilia, cytopenia) 4 or more


Final classification of the reaction as definite (score >17), probable (14-17), possible (10-13), unlikely (6-9), and excluded (<6).

well as extrahepatic manifestations (maximum of 3 scores each). Deliberate rechallenge of an incriminated drug is ethically unjustifiable and inadvertent re-exposure is reported in a minority (8.8%) of hepatic ADRs (unpublished data). Extrahepatic manifestations, considered to represent immuno-allergic reaction, are infrequent with hepatotoxi-city due to many of the currently used drugs (Banks et al, 1995; Hautekeete et al, 1999). None of the 180 patients in a large series of diclofenac hepatotoxicity would have scored maximum points for this component on the CDS (Banks et al., 1995). Even though underscoring by the CDS attributes a lower level of probability to an individual drug-related hepatotoxic reaction, a cut-off CDS score of >9 still remains useful in grouping the reactions that require further investigations and those wherein withdrawal of the drug is justified (Aithal et al., 2000). Moreover, a numerical "cut-off" is far easier to apply in routine clinical practice.

Systematic evaluation using causality assessment methods such as international consensus criteria or a clinical diagnostic scale provides objectivity and consistency to the assessment of suspected adverse hepatic drug reactions. Their more widespread adoption should enhance the accuracy of case definition for epidemiological studies.

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