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Chapter: Pharmacovigilance: Renal Adverse Drug Reactions

The interpretation of incidence data of renal adverse reactions is hampered by the absence of a uniform definition.


The interpretation of incidence data of renal adverse reactions is hampered by the absence of a uniform definition. However, drug-induced nephrotoxicity is a major cause of hospital-acquired ARF contributing to 4–19% of the cases (Hou et al., 1983; Shusterman et al., 1987; Nash, Hafeez and Hou, 2002; Payen and Berton, 2005), also in developing coun-tries (Jha et al., 1992). Antibiotics (aminoglyco-sides, amphotericin B and piperacillin), non-steroidal anti- inflammatory drug (NSAIDs), cyclosporine and angiotensin-converting enzyme (ACE) inhibitors are high on the list (Nash, Hafeez and Hou, 2002). Especially in the setting of the intensive care unit (ICU), drug-induced renal failure is very frequent. The reason is that many precipitating factors such as hypovolaemia, true hypovolaemia or reduced effec-tive circulating volume, sepsis, older age and the concomitant administration of other nephrotoxins, are present in ICU patients.

In the general community, drug-induced ARF is rare (Liano and Pascual, 1996), although its incidence may be growing due to the increased use of ACE inhibitors in combination with diuretics in the elderly population (Baraldi et al., 1998). In children drugs are a rare cause of ARF (Moghal, Brocklebank and Meadow, 1998).

Renal adverse effects also contribute to the burden of chronic renal disease. In the 1980s, in some coun-tries like Belgium, Switzerland and Australia, up to 20% of dialysis patients were suffering from anal-gesic nephropathy. In these patients, renal papillary necrosis induced by chronic abuse of analgesics lead to CRF. Prospective studies firmly linked the disease to the chronic use of analgesic mixtures. The rela-tionship has been established for mixtures containing phenacetin (Dubach, 1983) as well as for mixtures not containing phenacetin (Elseviers and De Broe, 1995). In the same patients, urinary tract tumours were also more prevalent. Nowadays, the disease is disappear-ing following legislative measures limiting the free access to the incriminated drugs.

The calcineurin inhibitors cyclosporine and tacrolimus are immunosuppressant agents used after organ transplantation and in the treatment of psoriasis and autoimmune diseases. The main adverse effect of these drugs not related to their immunosuppres-sive action is nephrotoxicity. Calcineurin nephrotox-icity is an important contributor to the development of chronic graft failure after kidney transplantation and may lead to end-stage renal disease in heart and liver allograft recipients. Even short-time courses of cyclosporine may induce structural damage in psori-asis patients (Vercauteren et al., 1998).

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