Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Ezetimibe
Post-marketing Experience
Simvastatin
Laboratory Tests
Concomitant Lipid-Lowering Therapy
Other adverse experiences reported with ezetimibe in placebo-controlled studies, regardless of causality assessment:
Body as a whole – general disorders: fatigue; Gastrointestinal system disorders: abdominal pain, diarrhea; Infection and infestations: infection viral, pharyngitis, sinusitis; Musculoskeletal system disorders: arthralgia, back pain; Respiratory system disorders: coughing.
The following adverse reactions have been reported in post-marketing experience, regardless of causality assessment:
Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria; arthralgia; myalgia; elevations in liver transaminases; hepatitis; thrombocytopenia; pancreatitis; nausea; dizziness; paresthesia; depression; cholelithiasis; cholecystitis; elevated creatine phosphokinase; and, very rarely, myopathy / rhabdomyolysis.
Other adverse experiences reported with simvastatin in placebo-controlled clinical studies, regardless of causality assessment:
The following effects have been reported with other HMG-CoA reductase inhibitors. Not all the effects listed below have necessarily been associated with simvastatin therapy.
Marked persistent increases of serum transaminases have been noted. About 5% of patients taking simvastatin had elevations of CK levels of 3 or more times the normal value on one or more occasions. This was attributable to the noncardiac fraction of CK. Muscle pain or dysfunction usually was not reported omyolysis).
In controlled clinical studies in which simvastatin was administered concomitantly with cholestyramine, no adverse reactions peculiar to this concomitant treatment were observed. The adverse reactions that occurred were limited to those reported previously with simvastatin or cholestyramine.
Adolescent Patients (ages 10-17 years)
In a 48-week controlled study in adolescent boys and girls who were at least 1 year post-menarche, 10-17 years of age with heterozygous familial hypercholesterolemia (n=175), the safety and tolerability profile of the group treated with simvastatin (10-40 mg daily) was generally similar to that of the group treated with placebo, with the most common adverse experiences observed in both groups being upper respiratory infection, headache, abdominal pain, and nausea.
Adapted from the FDA Package Insert.