WASHINGTON, D.C. -- September 19, 2003 -- The cholesterol-lowering drug, rosuvastatin (Crestor) is unsafe and should not have been approved by the federal Food and Drug Administration (FDA), according to the consumer organization, Public Citizen. The group has issued a "Do Not Use" warning about Crestor, saying it may cause kidney damage or rhabdomyolysis. Rhabdomyolysis is a condition in which muscle cells break down, releasing myoglobin, and causing muscle destruction. Because myoglobin can be toxic to kidneys, the result may be severe kidney damage or failure.
Crestor is one of six compounds called statins that are used to lower lipids and cholesterol. The FDA approved Crestor in August, 2003. However, the agency's own Advisory Committee recognized that at certain doses, Crestor could lead to kidney failure ( FDA Advisory Committee Meeting, June 11, 2003). Some patients taking Crestor also had an increased frequency of protein in their urine (proteinuria) and blood in the urine (hematuria), that was associated with kidney problems.
"It was irresponsible of the FDA to approve rosuvastatin without requiring routine urine testing for protein and blood to monitor for the early signs of kidney damage," said Sidney Wolfe, M.D., director of Public Citizen's Health Research Group. "This drug is already showing signs that it is too dangerous for people to take, and it is only a matter of time, after 'enough' people have been injured or killed, that it will have to be pulled from the market."
Another statin, cerivastatin (Baycol), was removed from the market because of at least 31 reports of fatal rhabdomyolysis. Instead of using Baycol or Crestor, Public Citizen recommends the use of either of three other statins -- lovastatin, pravastatin, and simvastatin. These drugs provide better benefits in lowering cholesterol and pose less risk, according to the group.
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