Cerivastatin is the most potent statin (it’s an HMG-CoA reductase inhibitor); it was marketed in 1997 and used for the treatment of patients with hypercholesterolemia. The withdrawal of cerivastatin from the world market was in 2001 because of several cases of rhabdomyolysis as a result of its administration at high doses or in association with fibrates (gemfibrozil). The case of cerivastatin highlighted the pharmacovigilance system lacks and provided the improvement and encouraged the development of new legislations.
La cerivastatina è una potente statina (inibitore della HMG-CoA reduttasi), commercializzata nel 1997 per il trattamento della ipercolesterolemia. Questo farmaco è stato ritirato dal commercio nel 2001 a causa dei numerosi casi di rabdomiolisi in seguito al suo impiego ad alti dosaggi o in associazione con fibrati (gemfibrozil). IL caso cerivastatina ha messo in luce tutte le lacune del sistema di farmacovigilanza permettendone la correzione e stimolandone lo sviluppo con nuove normative
Farmacovigilanza: il caso cerivastatina
CHIEPPA, GIOVANNI CARMINE
2016/2017
Abstract
Cerivastatin is the most potent statin (it’s an HMG-CoA reductase inhibitor); it was marketed in 1997 and used for the treatment of patients with hypercholesterolemia. The withdrawal of cerivastatin from the world market was in 2001 because of several cases of rhabdomyolysis as a result of its administration at high doses or in association with fibrates (gemfibrozil). The case of cerivastatin highlighted the pharmacovigilance system lacks and provided the improvement and encouraged the development of new legislations.È consentito all'utente scaricare e condividere i documenti disponibili a testo pieno in UNITESI UNIPV nel rispetto della licenza Creative Commons del tipo CC BY NC ND.
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https://hdl.handle.net/20.500.14239/23174