Important information about ezetimibeWhen ezetimibe is used with a statin, liver function tests should be performed at the start of therapy and after that in accordance with the label for that statin.  Due to the unknown effects of the increased exposure to ezetimibe in patients with moderate or severe hepatic insufficiency, ezetimibe is not recommended in these patients.  In clinical trials, there was no increased incidence of myopathy or rhabdomyolysis associated with ezetimibe.  However, myopathy and rhabdomyolysis are known adverse reactions to statins and other lipid-lowering drugs.  There are no adequate and well-controlled studies of ezetimibe in pregnant women.  Ezetimibe should not be used in pregnant or nursing women unless the benefit outweighs the potential risks.  The safety and effectiveness of ezetimibe with fibrates have not been established; therefore, co-administration with fibrates is not recommended.

Important information about simvastatinSimvastatin should not be used by anyone allergic to any of its components, with liver disease, or by women who are pregnant, breast-feeding or likely to become pregnant.  Muscle pain or weakness in people taking simvastatin should be reported to a doctor because these could be signs of a serious side effect.  Doctors may perform blood tests before and periodically during treatment with simvastatin to check for liver problems.  People taking 80 mg of simvastatin should receive an additional liver function test at three months.  To help avoid serious side effects, discuss with your doctor medicine or food you should avoid while taking simvastatin.  In clinical trials, adverse reactions usually have been mild and transient.  Most common side effects included headache (3.5 percent), abdominal pain (3.2 percent) and constipation (2.3 percent).