[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
[Skip to Content Landing]
May 15, 1996

Carcinogenicity of Lipid-Lowering Drugs

Author Affiliations

Merck Research Laboratories Rahway, NJ

JAMA. 1996;275(19):1480-1481. doi:10.1001/jama.1996.03530430023029

To the Editor.  —Drs Newman and Hulley1 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