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- Title
Fluvastatin and hepatic reactions: a signal from spontaneous reporting in Italy.
- Authors
Conforti, Anita; Magro, Lara; Moretti, Ugo; Scotto, Stefania; Motola, Domenico; Salvo, Francesco; Ros, Barbara; Leone, Roberto
- Abstract
Signal detection is a crucial element in recognising new adverse drug reactions (ADRs) as soon as possible. HMG-CoA reductase inhibitors ('statins'), the most potent cholesterol-lowering drugs, are generally well tolerated but can occasionally lead to liver toxicity. Pre- and postmarketing studies on statins revealed an incidence of 0.1-3% elevation in hepatic transaminase levels. However, these elevations are asymptomatic, reversible, dose related or probably due to other causes. Postmarketing studies clearly showed the lack of evidence of hepatotoxicity from statins, apart from some isolated case reports of serious hepatic damage described in the literature. It is still unclear whether serious hepatic reactions are dose related and more frequent than the expected rate in the general population.
- Publication
Drug safety, 2006, Vol 29, Issue 12, p1163
- ISSN
0114-5916
- Publication type
Journal Article
- DOI
10.2165/00002018-200629120-00007