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Warning About Crestor

New Crestor warnings have recently been issued by European and Canadian regulators, attempting to strengthen labeling requirements on the cholesterol-lowering product that has been linked to rare and potentially life-threatening side effects at high dosages. A warning label, released by Crestor manufacturer Astra-Zeneca Pharmaceuticals, tells doctors in all 22 EU countries to start their patients on the low 10-milligram dose of Crestor instead of higher dosages for a four-week trial period. Crestor labels in the United States already carry this warning, the FDA claims. Health Canada has also recently issued a warning to its citizens, explaining the high risk for life-threatening side effects, while the scientific journal The Lancet decided to publish a letter from Dr. Sidney Wolfe of Public Citizen, demanding that Crestor be pulled from shelves immediately.

Crestor is a prescription drug used to lower patients' cholesterol when natural measures have been unsuccessful. While it has been effective on its own, Crestor should be used in addition to a healthy diet and regular physical activity. Crestor lowers cholesterol by reducing the amount of fatty LDL's, or so-called "bad cholesterol," in the blood. It also raises the amount of HDL's, or "good cholesterol," creating an overall reduction in the body's cholesterol level. Crestor falls into the statin category, a popular and prevalent class of cholesterol-fighting pharmaceuticals. Statins work to reduce the risk of heart disease and stroke in patients with abnormally high cholesterol levels. But along with their health benefits, all statins have a dangerous potential side effect. They put the patient at risk for injury to the body's muscle tissue, and can cause a muscle-destroying disease called rhabdomyolysis. When rhabdomyolysis dissolves muscle tissue it releases substances that are harmful to the kidney and potentially life-threatening.

The extent of the physical side effects from Crestor was unknown at the time the FDA approved the drug for distribution in the United States. Although Public Citizen, a consumer watchdog group, protested the approval of Crestor and had it delayed by nearly a year, the FDA found no adverse effects on the muscles during the clinical trials of the product at appropriate doses. But within the first year after Crestor was available for prescription, a 39-year old American woman died from kidney damage as a result of rhabdomyolysis. In addition, a handful of patients throughout the U.S., U.K. and Canada had suffered serious side effects while taking Crestor at normal doses, including kidney damage and kidney failure.

This prompted Public Citizen to petition the FDA for a ban on Crestor, alleging that its side effects are more dangerous than any other statin because of the muscle damage produced in the absence of rhabdomyolysis. Crestor manufacturer Astra-Zeneca maintains that their product is no different than any other statin on the market today, with over two million Crestor prescriptions written to date. Despite this claim, the FDA continues to warn physicians to recommend appropriate dosages for their patients and inform them of the potential risk of muscle injury that can be caused by Crestor. Patients taking Crestor or any other statin, the FDA says, should call their doctor immediately if they exhibit symptoms such as vomiting, nausea, dark urine, fever, or muscle pain.

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