Carcinogenicity of Lipid-Lowering Drugs

Abstract

To the Editor. —Drs Newman and Hulley 1 question the US Food and Drug Administration (FDA) decision to approve inhibitors of HMG-CoA reductase (statins) for prescription because high doses increased the background tumor incidence in rodent lifetime carcinogenicity studies. This information is not new and has been available in the package circulars since the first member of the class (lovastatin) was approved in 1987. It is important to note that all the HMG-CoA reductase inhibitors are completely negative in a comprehensive battery of genotoxicity tests, while with the exception of estrogens all known organic chemical human carcinogens identified by the International Agency for Research on Cancer are genotoxic. 2 Simvastatin, lovastatin, and pravastatin were the subject of FDA Advisory Panel meetings that included review of the rodent carcinogenicity data, and in all 3 cases a unanimous vote for approval resulted. In the 2 large statin trials available to date, the