Simvastatin is drug with hypolipidemic or antihyperlipidemic agents which classed as statin to treats the abnormal levels of lipids, lipoprotein, or both of them in the blood.
The purpose is to prevent cardiovascular disease.
Several brand market available from any pharmaceutical company.
One of them is Zocor from Merck/Schering-Plough Pharmaceuticals, including combination with ezetimibe and niacin such as Vytorin from Merck/Schering-Plough Pharmaceuticals and Simcor from Abbott Laboratories.
However, recent alert from FDA today related to safety and adverse effects based on the review of SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) trial, said that high dose of Simvastatin will increased the risk of muscular disease, Myopathy.
The trial evaluates comparasion dosage use 80 mg (6031 patients) vs 20 mg (6033 patients) who have cardiovascular events such as heart attack, cardiovascular death, and revascularization.
This is including follow-up study for 6.7 years.
For instance FDA suggest healthcare professional to give more attention and consider with following conditions;
- Rhabdomyolysis as most serious form of myopathy and associated with sever renal toxicity and failure, is a rare class effect associated with statins,
- 80 mg dose could increased the risk of muscle injury compared with low dose,
- Despite this drug appropriate clinically, intensive discussion to the patients related to benefits and risk is important,
- This drug may interaction with other drug,
- Simvastation is one of 27 drugs categorized under FDA watch list related to signs of serious risks.
As adverse effect to myopathy, recent study issued of the Journal of American College of Cardiology published on October 20, 2009 found that risk for myopathy may be linked to genetic heterogeneity in statin users.
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