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Crestor (rosuvastatin), is a synthetic lipid-lowering agent for oral administration, which is marketed as by AstraZeneca. It is a class of drugs known as HMG-CoA reductase inhibitors (statins). It slows down the production of cholesterol and reducing buildup of cholesterol on artery walls as well as increases good cholesterol (HDL), thus helps to prevent heart disease and reduces incidences of heart attacks and strokes. AstraZeneca, the manufacturer of Crestor received FDA approval in 2003. In March 2010, Crestor was approved as a preventive medicine for cholesterol control.
This drug is used in combination with exercise and diet to lower cholesterol and triglycerides (types of fat) in the blood and to slow the build-up of plaque (fatty deposits) in the blood vessels.
Major Side effects of Crestor:
- Memory loss.
- Type 2 diabetes.
- Liver damage.
- Muscle pain
- Rhabdomyolysis that can lead to kidney failure and death
Rhabdomyolysis is a rare condition that causes excessive deterioration of muscle tissue. When muscle tissue is broken down, myoglobin is released into the patient's bloodstream. However, excessive myoglobin can cause kidney damage. If left untreated, rhabdomyolysis can cause kidney failure and death.
Though Crestor is known as best-selling statin worldwide, it also caused serious complications such as heart problems, muscle damage and death. In 2005, the manufacturer of Crestor, Astra-Zeneca made a change in a label stating that the drug can cause serious muscle toxicity - the updated label reflected data from studies indicating that Asian people could be at an increased risk of muscle damage. The new label recommended that Asian patients be started on the 5 mg dose. When FDA was acknowledged about this drug with various health problems, FDA announced a label change in March 2012 to alert patients about the side effects and possible drug interactions linked to this statin. Again in October 2012, FDA announced to change Crestor's warning label to aware patients about the risk of immune-mediated necrotizing myopathy, an autoimmune myopathy associated with this drug.
Evidence to be looked for in potential cases:
- Usage of Crestor and other statins in Pharmacy Records.
- Duration of Crestor usage in Medical Records.
- Proof of injury and Treatment provided for injuries
Medical Record Review and claim validation of Crestor case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.