Monday, November 21, 2011

Crestor Side Effect Outline

Potential side effects of Crestor, a blockbuster cholesterol drug that has been used by millions of people, may be linked to an increased the risk of serious and potentially life-threatening Crestor heart problems, such as Crestor cardiomyopathy, as well as diabetes. Crestor (atorvastatin) was approved by the FDA in 2003 for the treatment of high cholesterol. It is a member of a class of cholesterol-lowering drugs known as statins. The drug is a direct competitor for Pfizer’s Lipitor and has a 12% market share of the $21 billion U.S. statin industry.

For the past year, Crestor, a statin drug originally approved to treat high cholesterol, has been increasingly used in people who don’t have a cholesterol problem as a way to prevent heart attacks or strokes. This expanded use was allowed despite growing concern about Crestor side effects, including liver damage, kidney damage, diabetes and a muscle disease called rhabdomyolysis.
The U.S. Food & Drug Administration approved the new Crestor indication last February, after reviewing a clinical study which showed a small reduction of strokes, heart attacks and other “cardiovascular events” among people taking the statin, compared with patients taking a placebo. The study was paid for by Astra Zeneca, the maker of Crestor.

Another possible Crestor side effect is liver damage. Certain drugs, including cyclosporine, Warfarin, gemfibrozil, some antacids, Tagamet and others taken with Crestor may increase the risk of liver damage, as can certain foods, like grapefruit. People taking Crestor are advised to undergo periodic liver enzyme tests to avoid this risk.Even when Crestor was first approved in 2003 there was controversy. When Crestor was first approved, the FDA did not approve the drug in stronger proposed doses because of serious Crestor kidney failure risks. Then in an October 29, 2004 press release, Public Citizen reported that the rate of kidney damage in Crestor patients is 75 times higher than in patients taking other cholesterol drugs. There had been 29 reports of acute kidney failure or renal insufficiency. In 2005, Public Citizen revealed that from October 1, 2003 through September 30, 2004 , the rate of rhabdomyolysis reports sent to the FDA per million prescriptions filled for Crestor was 6.2 times higher than the rate for all of the other statins combined (2.1 reports per million prescriptions filled).

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