Definitions and Diagnosis

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Chapter: Pharmacovigilance: Renal Adverse Drug Reactions

Since renal function is so diverse, it is impossible to give a unique definition of a renal adverse reaction.


DEFINITIONS AND DIAGNOSIS

Since renal function is so diverse, it is impossible to give a unique definition of a renal adverse reaction. The physiological role of the kidney and the clini-cal manifestation of malfunction are summarised in Table 38.1).


Drug-induced decrease in renal function is a major side effect in clinical practice. ARF is defined as an acute onset of severe deterioration of renal function necessitating renal replacement therapy. In the context of clinical studies, nephrotoxicity is more readily defined as a predefined level of decrease of renal func-tion. In chronic renal failure (CRF) deterioration of renal function proceeds more progressively. A clini-cal manifestation of drug-induced renal failure, that is particularly frequent, is the so-called acute-on-chronic renal failure. In this setting acute drug-induced injury is superimposed on chronically damaged renal tissue.

The absence of an effect on filtration function does not preclude a renal adverse effect. For exam-ple, due to renal salt wasting, polyuria and ortho-static hypotension may be the first manifestation of an adverse reaction of the tubulotoxin cisplatin (Hutchison et al., 1988).

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