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Bayer, the maker of Baycol, a statin approved by the Food & Drug Administration in 1997, withdrew Baycol from the market in August 2001 because of the risks of fatal rhabdomyolysis and renal failure.
Rhabdomyolysis, a serious muscle injury disease, is rarely fatal, but patients who were prescribed Baycol were ten times more likely to die from the muscle disease. Some of those deaths were caused when patients took Baycol along with gemfibrozil, another cholesterol-lowering agent. Other deaths occurred because patients were started at the highest possible dosages.
As with other statins, the risk of myopathy muscle weakness and rhabdomyolysis is dose-related.
The same can be said for Zocor or simvastatin (generic). Zocor also has serious contraindications and multiple drug interactions to be avoided. There is an increased risk of myopathy when Zocor is used concomitantly with fibrates (especially gemfibrozil). Combination therapy with gemfibrozil should be avoided.
According to the FDA, lower doses of simvastatin were not cause for alarm of rhabdomyolysis but the 80 mg dose is.
Simvastatin, like other statins, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatinine kinase (CK) above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred.
The risk of myopathy is increased by high levels of statin activity in plasma. Predisposing factors for myopathy include advanced age (older than 65 years), uncontrolled hypothyroidism, and renal impairment.
In the case of Zocor simvastatin, more is not better.
Are you the victim of 80 mg Zocor serious muscle weakness leading to kidney damage?
If the answer is yes, contact Monheit Law to find out what your legal options are. Big pharma needs to be responsible for dangerous or fatal prescription drug mistakes.