March 13, 2006
Despite New Information, Crestor Should Not Be Prescribed
Statement of Sidney M. Wolfe, M.D., Director of
Public Citizen’s Health Research Group
The study presented today at a meeting of the American College of Cardiology does not alter our assessment that Crestor has unique risks without evidence of unique benefits, that it should not be prescribed and that it should not have been approved by the Food and Drug Administration (FDA).
The relatively small size and short duration of the study, coupled with the lack of randomization, preclude any refutation of evidence from larger pre-approval randomized trials (and from post-approval reports) that the rates of muscle and kidney damage in patients who use Crestor are higher than in patients who use other currently marketed statins.
There still is no evidence that Crestor offers a unique benefit; even the study authors admit that we would probably see the same improvement in the narrowing of coronary arteries with other statins. Even more important, other statins, unlike Crestor, have been shown to reduce the occurrence of subsequent heart attacks.
The dose used in the study, 40 milligrams, is a dose that the FDA-approved labeling for the drug states should not be used unless patients fail to reduce their LDL cholesterol adequately with lower doses (5, 10 and 20 milligrams). It is unlikely that very many of the generally lower-risk patients in this study would therefore qualify for this high dose.
Finally, even the authors have failed to state that this study should prompt doctors to switch patients to Crestor.
Crestor is associated with an increased rate of rhabdomyolysis (muscle damage) and kidney damage. We repeat our call for the FDA to stop pandering to the pharmaceutical industry and start protecting patients by taking this drug off the market.