Thursday, January 26, 2012

Zocor Rhabdomyolysis Could Soon Lead to Lawsuits


A risk of Zocor muscle injury and similar drugs, known as statins, has been known for some time. However, it appears that the risk may be substantially increased when Zocor 80 mg doses are taken, and the manufacturer failed to adequately warn about the risk. In June, the FDA placed restrictions on the use of 80 mg Zocor, which could include twice-a-day 40mg doses, due to the risk of myopathy and Zocor rhabdomyolysis, a potentially life-threatening muscle injury. The FDA’s new recommendation was prompted by a seven-year study and patient reports that prove those taking the higher dosage of simvastatin have a greater risk of muscle injury than patients treated with lower doses or other statins.
Rhabdomyolysis from Zocor can occur when muscle damage caused by simvastatin causes the release of myoglobin into the blood stream. This may cause kidney damage as the organ attempts to filter it out of the body, potentially leading to kidney failure or death in some cases. Similar warnings were also added about the risk of rhabdomyolysis from side effects of Vytorin and Simcor, where the cholesterol drugs may be prescribed at levels that contain an 80 mg daily dose of simvastatin, the active ingredient in Zocor. Vytorin combines simvastatin with exetimibe, while Simcor combines simvastatin with niacin. Symptoms of rhabdomyolysis side effects may start with unexplained muscle cramps, tenderness, stiffness, pain or spasm.
The presence of myoglobin in the blood stream, or elevated muscle enzymes, may also cause dark or red-colored urine, which is often described as “tea colored.” Other possible symptoms of problems from rhabdomyolysis may include nausea, vomiting, confusion, coma or abnormal heart rate. The only good news to come from this study is that Zocor users can often stop and even reverse the symptoms of Zocor rhabdomyolysis. This requires that the condition be discovered as early as possible. The cholesterol-lowering drug may be in hot water but safety groups like Public Citizen have argued that the FDA did not go far enough in its warnings against Zocor and that the drug should be recalled due to the imminent threat that it offers its patients.

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