ezetimibe and simvastatin (cont.)
NURSING MOTHERS: Because of the risk of adverse effects to the developing
infant, Vytorin should not be administered to
nursing mothers.
SIDE EFFECTS: The most common side effects of Vytorin are headache, nausea,
vomiting, diarrhea, 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.
The simvastatin component of Vytorin is a statin. Therefore it shares side
effects, such as liver and muscle damage associated with 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 Vytorin is started and periodically thereafter or if there is a
medical concern about liver damage. Liver tests should be performed before the
10/80 mg dose of Vytorin 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 Vytorin should contact their healthcare provider immediately if they
develop unexplained muscle pain, weakness, or muscle tenderness.
Reference: FDA Prescribing Information
Last Editorial Review: 4/16/2008
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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