Federal scientists say AstraZeneca’s cholesterol pill Crestor lowers the risk of heart attack, death and stroke in patients without a history of heart disease, though some safety concerns remain.
In documents posted online Friday, the Food and Drug Administration cites the findings of AstraZeneca’s study released last November. The study showed that patients with lower cholesterol and few heart risks could still benefit from taking Crestor, setting the stage for a dramatic expansion in use of the drug that already exceeds $1 billion in annual sales.
The British drugmaker wants the FDA to broaden Crestor’s labeling based on those results.
But the FDA’s review also cites several safety concerns, including a higher rate of diabetes in patients taking Crestor.
About 2.8 percent of patients taking Crestor in the 17,000-patient Jupiter study developed diabetes, compared with 2.3 percent of patients taking a dummy pill. The difference was statistically significant, according to the FDA. Read more…
