Astra-Zeneca Pharmaceuticals released a revised package insert for Crestor (rosuvastatin) due to prompting by the U.S. FDA over results from a Phase 4 pharmacokinetic study in Asian-Americans. The FDA issued another Public Health Advisory on Crestor (rosuvastatin) due to its link in rhabdomyolysis, a devastating wasting disorder of the muscles the can lead to kidney failure and death.

Current labeling changes were made by the FDA after a study involving a diverse population of Asian-Americans in which levels of rosuvastatin in the blood were found to be elevated approximately two-fold compared with a Caucasian control group. As a result of these findings, the “Dosage and Administration” section of Crestor’s label now states that the 5 mg. dose of Crestor should be considered as the start dose for Asian patients, and any increase in dose should take into account these study findings that increased drug exposure in this population doubles the amount of Crestor remaining in the bloodstream, increasing the risk of dangerous side-effects linked to the medication.

The advisory also revised the warning section of the label to more strongly emphasize the risk of myopathy and /companies/astrazeneca-pharmaceuticals-lp/crestor/rhabdomyolysis.php) by stating that the 40 mg dose of Crestor (rosuvastatin) is not an appropriate starting dose and should only be reserved for patients who have not achieved their cholesterol-lowering goals with the 20 mg dose.

All patients should be informed that the use of statins to lower cholesterol can cause muscle injury which in rare, severe cases can cause kidney damage and liver failure that are potentially life-threatening. Signs and symptoms of muscle disorder may include:

• Muscle pain
• Muscle weakness
• Fever
• Dark urine
• Nausea
• Vomiting