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FDA: Crestor has a favorable risk/benefit ratio


The Food and Drug Administration ( FDA ) issued a public health advisory, a patient information sheet and a corresponding healthcare professional information sheet further explaining the identified risks and benefits of Crestor ( Rosuvastatin ), a cholesterol-lowering drug.

Extensive review of the large amount of data available to date from controlled trials as well as the latest post-marketing safety information indicates that patients taking recommended doses of Crestor have a similar risk of rhabdomyolysis as patients on other statin cholesterol treatments.

In addition, Crestor's manufacturer AstraZeneca revised the package insert for Crestor, based on discussions with the FDA.
These changes re-emphasize recommendations made in the original label about the need for physicians to consider using lower starting doses of the drug in some individuals as a means of reducing the risk of rhabdomyolysis.

New information has been added to the labeling to reflect clinical and post-marketing adverse experiences seen in the 15 months following the approval of Crestor.

Consistent with other drug labeling in the statin class, irrespective of causality, jaundice has been added as a very rare event.

In addition, as with other statins, reports of rhabdomyolysis with Crestor are rare, but higher at the highest marketed dose ( 40mg ).

Initial instructions regarding usage of the 40 mg dose were made more explicit by strongly instructing that physicians reserve the 40 mg dose only for those patients who have not achieved their LDL-cholesterol goal utilizing the 20 mg dose of Rosuvastatin.

The revised labeling includes data from a pharmacokinetic study recently completed in the U.S., involving North-Americans of Asian descent. The results of this study showed higher drug exposure in this specific population relative to Caucasians.

Source: FDA, 2005

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