December 19, 2009 | Consumer Goods, Health & Medicine, Recent Studies
Cholesterol-lowering drug Crestor lowers the risk of heart attack, death and stroke in patients without a history of heart disease, according to federal health officials. The Food and Drug Administration is citing the findings of a 17,000-person study released last November in recommending the pill, although some safety concerns still remain.
About 2.8% of patients taking Crestor developed diabetes, compared to about 2.3% taking the placebo pill. The FDA found that the treatment benefit outweighs the risk, but further clinical studies are needed to determine the benefit-risk ratio. A panel of outside experts will discuss the diabetes development, along with the 13 deaths due to gastrointestinal disorders seen in Crestor patients.
AstraZeneca, maker of Crestor, wants the FDA to broaden the labeling based on the positive results of the study.
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