Crestor Side Effects Raise Concerns Over Increased Use

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 (FDA) 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.

In expanding Crestar’s approved uses, the FDA said the statin may be prescribed for apparently healthy people if they are older — men 50 and over and women 60 and over — and have one risk factor like smoking or high blood pressure, along with elevated inflammation in the body indicated by the CRP test. According to a report in the New York Times, an estimated 6.5 million healthy people in the U.S. would now be considered candidates for Crestor.

Not everyone was convinced, however, that expanded approval was a good idea, considering Crestor’s serious side effects. These include liver damage, kidney damage, diabetes and rhabdomyolysis. Critics of the FDA’s decision worried that the risks of giving Crestor to healthy people outweighed it benefits. In fact, the same month the FDA approved wider use of Crestor, a study published in The Lancet found that treating healthy people with statins like Crestor could raise a person’s risk of developing Type 2 diabetes by nine percent. The report analyzed 13 different studies about statin drugs, one of which showed a 25 percent increased risk in developing diabetes in those who take Crestor. One of the studies analyzed by the researchers was the very study the FDA relied upon to approve the expand use of Crestor.

Even when Crestor was first approved in 2003 there was controversy, with the patient advocacy group Public Citizen urging the FDA to deny its approval. 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 (13.1 reports per million prescriptions) was 6.2 times higher than the rate for all of the other statins combined (2.1 reports per million prescriptions filled). Because of these risks, the group has continually called for Crestor to be pulled from the market, to no avail.

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.

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