Rosuvastatin: renal disorders and rhabdomyolysis.
(1) Rosuvastatin was not evaluated for its impact on morbidity or mortality. In premarketing trials its adverse effects seemed similar to those observed with other statins. In addition, there were questions concerning renal adverse effects, particularly dose-dependent proteinuria. Inadequate information was available to know whether the risk of rhabdomyolysis differed from that of other statins. (2) A review of adverse events reported to the FDA in late 2004 showed that reports of renal and muscular adverse events were more frequent with rosuvastatin than with other statins currently on the market. (3) Regulatory agencies analysed their results and issued warnings, but they withheld the raw data. This is regrettable, especially given the frequent use of the drug, the specific risks associated with this class, and the questions that were left unanswered in its initial clinical evaluation. Healthcare professionals and the public need access to more precise data on rosuvastatin. (4) In practice, it is better to select the two statins with the most thorough clinical assessments, namely simvastatin and pravastatin.
D002986:Clinical Trials as Topic; D017277:Drug Approval; D005464:Fluorobenzenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005602:France; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D007674:Kidney Diseases / Q000139:chemically induced*; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D012206:Rhabdomyolysis / Q000139:chemically induced*; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use
D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides