FDA Panel to Consider Safety of Cholesterol Pill Crestor
A Food and Drug Administration advisory panel is going to look at reports of diabetes and other health complications associated with the blockbuster cholesterol-fighting pill Crestor, officials said.
According to a Reuters news report, Crestor’s maker, AstraZeneca Plc, wants the FDA to approve the drug for treating more conditions. The advisory panel’s recommendation on those expanded approvals will help the agency decide on whether to grant permission for Crestor to be marketed to reduce deaths, heart attacks, and strokes in middle-aged people with healthy cholesterol but elevated levels of C-reactive protein, which is associated with heart disease.
Before the advisory panel meeting next week, some FDA officials have already expressed concerns about increasing reports of diabetes reported with Crestor users and said the drug may have more risks than benefits when used to treat the additional conditions the drug company wants approvals for.
Crestor has long been linked to diabetes risks and other health complications. The drug accounted for $3.6 billion in annual sales in 2008, a 29-percent gain from the previous year, according to The Wall Street Journal.
While the FDA is not obligated to follow the recommendations of its advisory panels, most of the time, it does. So, the word from the Crestor advisory panel is being closely watched for a possible indication of how the FDA will proceed with broader approvals for the popular drug.
The group of outside experts will be asked to comment on the findings from a recent study of Crestor’s performance in treating the additional conditions then decide whether to recommend approval. The FDA also will seek input on a higher number of patients who reported a “confusional state” in the Crestor group, according to an FDA memo said.
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