FDA Public Health Advisory for Crestor (rosuvastatin)
June 9, 2004 17:51

Astra-Zeneca Pharmaceuticals today released a revised package insert for Crestor (rosuvastatin) for use in the 22 member states of the European Union (EU). The changes to the European labeling are in response to postmarketing spontaneous 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 theU.S. FDA is alerting physiciansto the need 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.

Healthcare professionals prescribing Crestor are reminded of the following key safety messages from the Crestor label: start doses and maintenance doses of drug should be based on individual cholesterol goals and apparent risks for side-effects; all patients should be informed that statins can cause muscle injury, which in rare, severe cases, can cause kidney damage and other organ failure that are potentially life-threatening; and patients should be told to promptly report to their physician signs or symptoms of muscle pain and weakness, malaise, fever, dark urine, nausea, or vomiting.