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simvastatin (cont.)

PREGNANCY: Pregnant women should not use simvastatin because the developing fetus requires cholesterol for development, and simvastatin reduces the production of cholesterol. Simvastatin should only be administered to women of child bearing age if they are not likely to become pregnant.

NURSING MOTHERS: Because of the risk of adverse effects to the developing infant, simvastatin should not be administered to nursing mothers.

SIDE EFFECTS: The most common side effects of simvastatin are headache, nausea, vomiting, diarrhea, abdominal pain, muscle pain, and abnormal liver tests. Hypersensitivity reactions have also been reported. The most serious potential side effects are liver damage and muscle inflammation or breakdown.

Simvastatin is a statin. Therefore it shares side effects, such as liver and muscle damage associated with all statins. Serious liver damage caused by statins is rare. More often, statins cause abnormalities of liver tests, and, therefore, periodic measurement of liver tests in the blood is recommended for all statins. Abnormal tests usually return to normal even if a statin is continued, but if the abnormal test value is greater than three times the upper limit of normal, the statin usually is stopped. Liver tests should be measured before simvastatin is started and periodically thereafter or if there is a medical concern about liver damage. Liver tests should be performed before the 80 mg dose of simvastatin is initiated, three months after initiation and then periodically thereafter.

Inflammation of the muscles caused by statins can lead to a serious breakdown of muscle cells called rhabdomyolysis. Rhabdomyolysis causes the release of muscle protein (myoglobin) into the blood. Myoglobin can cause kidney failure and even death. When used alone, statins cause rhabdomyolysis in less than one percent of patients. To prevent the development of rhabdomyolysis, patients taking simvastatin should contact their healthcare provider immediately if they develop unexplained muscle pain, weakness, or muscle tenderness.

Reference: FDA Prescribing Information


Last Editorial Review: 9/16/2008




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