As reported by the consumer group Public Citizen, AstraZeneca originally filed its application with the FDA to market rosuvastatin in June 2001. The application was delayed after reports of kidney damage and muscle weakness (an early signal for rhabdomyolysis) in clinical trials in patients taking 80 milligrams of the drug per day. The company stopped development of the 80 milligram dose, and rosuvastatin will only be sold in 5, 10, 20, and 40 milligram strengths. There will also be special restrictions on the distribution of the 40 milligram strength.
Public Citizen opposed the approval of rosuvastatin because it alleged that the drug causes abnormal elevations in urine protein and blood that are signals for serious kidney toxicity, and is the only statin that has shown life-threatening rhabdomyolysis in pre-approval clinical trials.
Rhabdomyolysis is a potentially life-threatening condition that occurs when a large number of skeletal muscle cells die, resulting in the release of a massive amount of muscle protein (known as myogloblin) into the bloodstream. The muscle protein can become trapped in the kidneys, clogging up the filtering process of the kidneys and leading to kidney or renal failure. In addition, potassium released from the damaged muscle cells can cause malignant heart rhythms resulting in cardiac arrest.
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