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Crestor, the cholesterol drug made by AstraZeneca, does not significantly reduce the heart problems of patients who are on dialysis, according to research released today.
Reuters is reporting that the 2,776-patient Aurora study "failed to reach the primary goal of reducing combined heart attacks, strokes and cardiovascular death," which "dampened hopes for reducing heart risks in patients with serious renal disease, who are vulnerable to cardiovascular problems."
Crestor (rosuvastatin calcium) is a statin drug, meaning that it lowers "bad" cholesterol and triglycerides, and raises "good" cholesterol in the blood. Crestor is made by AstraZeneca Pharmaceuticals LP, and was approved by the FDA in 2003.
But Crestor's safety history is not without controversy. In March 2005, the FDA issued an alert on reports of serious muscle damage in patients taking statin drugs, and Crestor's labeling was revised to warn of that risk. Crestor has also appeared in abnormally high levels in the blood of Asian patients.
While most prescription drugs like Crestor have certain side effects, drug manufacturers must make medicines as reasonably safe as possible, and inform the medical community and patients of known risks associated with certain medicines. Prescription drug makers can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of a drug, under a legal theory called "product liability." Learn More About Product Liability Cases.