Crestor is in a class of drugs called “statins.” Statins work by stopping an enzyme called HMG-CoA reductase from making cholesterol. High cholesterol is a known risk factor for heart attacks and strokes.
Crestor is approved to lower cholesterol and triglycerides in combination with diet and exercise in patients with high cholesterol and/or triglycerides, to slow the progression of atherosclerosis, and for the primary prevention of cardiovascular disease to reduce the risk of stroke, heart attack, and the risk of arterial revascularization procedures.
As with any drug there are several side effects, or potential adverse reactions. Common symptoms are constipation, heartburn, dizziness, difficulty falling asleep or staying asleep, depression, joint pain, and cough.
The following symptoms are said to be uncommon, but are indeed a potential risk, and they include; muscle pain, tenderness, or weakness, lack of energy, fever, chest pain, yellowing of the skin or eyes, pain in the upper right part of the abdomen, nausea, extreme tiredness, unusual bleeding or bruising, loss of appetite, flu-like symptoms, sore throat, chills, or other signs of infection, rash, hives, itching, difficulty breathing or swallowing, swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs, hoarseness, or numbness or tingling in fingers or toes.
And, if this is not enough, there are yet 3 more very serious potential reactions, such as Myopathy, kidney damage, and liver damage.
Myopathy refers to any disease that affects muscle tissue. Diseases of the muscle result in weakness, inflammation, tetany (spasms), or paralysis. Myopathy can be the result of either inherited or acquired causes.
Studies suggest that between 10% and 15% of patients who take cholesterol-lowering statin drugs like Crestor, experience muscle pain as a side effect of treatment.
Various forms of kidney failure have also been reported in patients taking Crestor. Renal failure due to other factors is known to occur at a higher rate in patients who are candidates for statin therapy (e.g., patients with diabetes, hypertension, atherosclerosis, heart failure).
Mild, transient proteinuria (or protein in the urine, usually from the tubules), with and without microscopic hematuria (minute amounts of blood in the urine), occurred with Crestor, as it has with other statins, in Crestor’s pre-approval trials. The frequency of occurrence of proteinuria appeared dose-related. It is recommended, that a dose reduction and an investigation into other potential causes be considered if a patient on Crestor develops unexplained, persistent proteinuria.
Most doctors believe that statins are safe for long-term use, and important liver injury is rare. Nevertheless, statins can also injure the liver. The most common liver-related problem caused by statins is mild elevations in blood levels of liver enzymes (ALT and AST) without symptoms. Clinical studies have found elevations in 0.5% to 3% of patients who take statins.
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.
Because these aforementioned reactions are indeed very severe, one doctor by the name of Dr. Sidney Wolfe, actually petitioned the FDA to remove Crestor from the market in March of 2004. Unfortunately the FDA ruled against the removal and Dr. Wolfe’s request was unfortunately denied. They found that sufficient evidence was not presented to warrant the removal.