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U.S. Department of Health and Human Services

Safety

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Crestor (rosuvastatin) Jun 2004

Audience: Physicians, pharmacists, and other healthcare professionals

FDA issued a Public Health Advisory notifying healthcare professionals of a revised package insert for use in the 22 member states of the European Union (EU). The changes to the European labeling are in response to adverse event reports in patients receiving Crestor and highlight certain patient populations who may be at an increased risk for serious muscle toxicity (myopathy) associated with Crestor use, especially at the highest approved dose of 40 mg. These risk factors and many of the recommendations for how to minimize the risk of myopathy are already captured in the FDA approved labeling for Crestor in the U.S. FDA alerted physicians to carefully read the Crestor product label and follow the recommendations for starting doses, dose adjustments, and maximum daily doses to minimize the risk of myopathy in individual patients.

[June 09, 2004 Public Health Advisory - FDA]