Simvastatin

Simvastatin Side Effects:  Simvastatin’s brand name is Zocor (see Zocor side effects) and is a cholesterol lowering medication in the class called statins.  Simvastatin is available in 5 mg, 10 mg, 20 mg, 40 mg  and 80 mg doses.  This class of medications is used primarily for lowering LDL cholesterol to reduce the chances of developing atherosclerotic vascular disease.  Simvastatin also has FDA approved indications for mixed hyperlipidemia, type 4 hyperlipidemia, dysbetalipoproteinemia, homozygous familial hypercholesterolemia, and cardiovascular adverse event prophylaxis in patients at high risk for heart attack or other cardiovascular events due to diabetes, known coronary heart disease or peripheral vascular disease.  Like all statins simvastatin has the risk of serious side effects.

Restricted Use of 80 mg Simvastatin:  Effective in June 2011 the FDA recommends limiting the dose of simvastatin to a maximum dose of 40 mg, with the exception of patients already taking simvastatin 80 mg daily for a period of greater than 12 months who have not developed any myalgia side effects.  The FDA make this restriction because at the highest dose of simvastatin 80 mg daily the incidence of serious myopathy was higher than using other available statins.  Patients stable on simvastatin 80 mg for longer than a year without myopathy as a side effect may be kept on this dose.  New patients should not be started or increased to simvastatin 80 mg, rather an alternative statin should be used when additional lipid lowering is needed that is not achieved with simvastatin 4omg.  Options may be Lipitor, Crestor or adding an additional lipid lowering drug to the simvastatin.  It is felt that the incidence of Lipitor side effects and Crestor side effects is lower than simvastatin side effects at 80 mg dosing.

Common Simvastatin Side Effects:  Common simvastatin side effects include myalgia which is felt by many physicians to be the most common simvastatin side effect, and is unfortunately common with all statin medications.  Other common simvastatin side effects include liver related issues including elevated liver transaminases and elevated creatine kinase (a muscle enzyme).   Gastrointestinal simvastatin side effects may be abdominal pain, constipation, flatulence or diarrhea.  Asthenia and URI symptoms may also be common simvastatin side effects.

Serious Simvastatin Side Effects:  Among the serious simvastatin side effects myopathy is the most common, and may range from minor aching and pain to severe muscle inflammation, rhabdomyolysis with renal failure and death.  Hepatotoxicity may be minor with elevation of liver transaminases as mentioned above or more serious hepatitis.  In general if the liver transaminases are elevated more than 3x baseline the dose of simvastatin may need to be reduced or the medication stopped.  Pancreatitis, acute renal failure (usually from rhabdomyolysis), anaphylaxis, angioedema, and interstitial lung disease are potential serious simvastatin side effects.  Serious dermatologic reactions can include Steven’s Johnson Syndrome, toxic epidermal necrolysis, erythema multiforme, and photosensitivity.  Rheumatologic disorders including dermatomyositis, polymyalgia rheumatica, vasculitis and lupus erythematosis are reported.  Other hypersensitivity syndromes are possible.  Serious hematologic simvastatin side effects can be leukopenia, hemolytic anemia and thrombocytopenia.

Cautions and Drug Interactions:  Simvastatin is contraindicated in pregnancy and lactation, and should not be given to women of child bearing age who may become pregnant without excellent contraception and a strong indication.  The potential for hepatotoxicity makes active liver disease, hepatitis, and significant alcohol use a caution.  Preexisting muscle disease like myopathy is a strong caution.  For a complete list of cautions and contraindications see the manufacturer’s prescriber information.  Contraindications for concurrent use due to drug interaction concerns include the azole antifungal medications like ketoconazole and itraconazole, erythromycin classes of drugs, multiple antiviral HIV drugs, and cyclosporine.  Use with other drugs with potential hepatic toxicity is a relative contraindication.  The list of drugs with potential drug interactions or relative contraindications is extensive and the reader should consult the manufacturer’s guidelines for a complete list.

Pregnancy and Lactation:  Pregnancy Category X, meaning that there is positive evidence of human fetal risks that outweigh any potential benefit and that simvastatin (as well as all other available drugs in the statin class) should not be used in pregnancy.  Simvastatin use in lactation is considered possibly unsafe.

Unusual Simvastatin Side Effects:  The myalgia simvastatin side effects can vary in severity and symptoms, but are relatively common and fairly uncommon with other medications.  Patients may complain of weakness, muscle pain, excessive aching or pain after physical exertion, or just vague pain all over.

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