Highest Dose of Zocor Banned By FDA Due To Muscle Damage

In June 2011, the FDA issued a warning to doctors about potential side effects of Zocor when used at high doses (80 mg), saying that the cholesterol drug may increase the risk of Zocor muscle injury or myopathy. The warning came after more than a year of FDA experts reviewing clinical trials on Zocor and other drugs containing simvastatin, which had been available to the manufacturers for some time.  The FDA warns that the 80 mg dose of Zocor carries an increased risk of muscle injury,

particularly in the first year of use. The high dose of the medication may cause users to face a risk of myopathy or rhabdomyolysis; rare forms of muscle injury.

In a clinical trial database where 41,050 patients were treated with Zocor with 24,747 (approximately 60%) treated for at least 4 years, the incidence of myopathy was approximately 0.02%, 0.08% and 0.53% at 20, 40 and 80 mg./day, respectively. Myopathy is a muscular disorder that interferes with the proper function of muscle fibers. Depending on the severity, a person suffering myopathy may find the muscles are so weak that performing routine tasks is extremely difficult, if not impossible. Myopathy is a muscle disease which can result in muscle pain, tenderness, weakness or an elevation of muscle enzyme in the blood (reatine kinase or CK). The most serious form of myopathy from using the statin drug can lead to Zocor rhabdomyolysis, which could cause serious and potentially life-threatening kidney damage or kidney failure.

The kidneys monitor the amount of body fluid, the concentrations of electrolytes like sodium and potassium, and balance of the body. The kidneys filter waste products in the blood like blood urea nitrogen or BUN and creatinine or Cr. With rhabdomyolysis, there is significant muscle breakdown in the body, and the degeneration products of muscle fibers clog the filtering system of the kidneys. Often occurring because of trauma and crush injuries, it can also be caused by some medications used to treat high cholesterol. If kidney disease gets worse, wastes can build to high levels in your blood and make you feel sick. You may develop complications like high blood pressure, anemia, weak bones, poor nutritional health, and nerve damage.