The U.S. Food and Drug Administration recently put out an alert to consumers warning them about an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor. FDA is comparing the effects of higher level of Zocor usage with patients taking lower doses of simvastatin or other drugs in the statin class.
Muscle injury or myopathy is a known side effect with all statin medications. The most common symptoms of myopathy are muscle pain, tenderness or weakness and an elevation of a muscle enzyme in the blood (creatine kinase). The higher the dose of statin used, the greater the risk of developing myopathy.
The most serious form of myopathy is known as rhabdomyolysis. This condition occurs when a protein or myoglobin is released as muscle fibers break down. Myoglobin can basically cause damage to the kidneys. Patients with rhabdomyolysis may experience symptoms such as dark or red urine, fatigue and muscle pain. It must be noted that kidney damage from rhabdomyolysis can be severe enough to cause kidney failure and death. Those who are above 65 years of age and have low thyroid function and poor kidney function are at a higher risk for rhabdomyolysis.
It is extremely important that healthcare professionals be aware of the potential for increased risk of muscle injury with 80 mg dose of simvastatin compared to lower doses. Patients who experienced muscle pain, tenderness or weakness, dark-colored urine or unexplained fatigue should contact their healthcare provider immediately.
In 2002, the FDA issued its first warning about the risk of rhabdomyolysis, advising healthcare professionals not to administer more than 20 mg per day of simvastatin to patients receiving heart drugs containing amiodarone such as Cordarone and Pacerone. In August 2008, the FDA issued another warning because it continued to receive reports of the muscle disease in patients taking both simvastatin and amiodarone. The agency reported that 52 more patients had developed rhabdomyolysis while taking simvastatin and amiodarone between the 2002 original warning and 2008.
Statins are the best-selling cholesterol-lowering drugs in the United States, with $14.5 billion in combined sales in 2008. These medications essentially use the liver to block the body’s creation of cholesterol, which is a key contributor to coronary artery disease. Statin is used in a number of other popular cholesterol controlling drugs, including Crestor, Lipitor, Mevacor, Lescol and Pravachol.
If you or a loved one has developed rhabdomyolysis and kidney damage from taking the 80 mg Zocor or similar simvastatin drugs, please contact an experienced Philadelphia pharmaceutical liability lawyer with Cherry Injury Law, to find out more information about how to pursue your legal rights. There are also many reports of patients having to resort to dialysis because of kidney damage caused by higher dosage simvastatins such as Zocor. Please call us today for a free consultation and evaluation of your claim.
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