Vytorin is a combination pill of a statin (simvastatin) and ezetimibe (Zetia). FDA officially approved Vytorin to lower LDL "bad" cholesterol, raise HDL "good" cholesterol, and lower triglycerides in adults with abnormal cholesterol levels from a genetic condition. The FDA-approved package insert currently says "Vytorin has not been shown to reduce heart attacks or strokes more than simvastatin alone (Zocor)". FDA is holding an Advisory Committee Meeting December 2015 to help decide whether to approve Vytorin for reducing heart attacks based on evidence from a new trial (IMPROVE-IT).
Genetic conditions include primary hypercholesterolemia (heterozygous familial and nonfamilial), mixed hyperlipidemia and homozygous familial hypercholesterolemia (HoFH)
Long track record means that new‚ unexpected side effects are unlikely. Vytorin was approved by FDA in 2004. Since Vytorin has now been used by large numbers of people over a long time‚ the emergence of important side effects is less likely than with new drugs.
Certain anti-fungal medicines (such as itraconazole, ketoconazole, posaconazole, or voriconazole), HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir, saquinavir, tipranavir, or atazanavir), certain hepatitis C virus protease inhibitors (such as boceprevir or telaprevir), certain antibiotics (such as erythromycin, clarithromycin, or telithromycin), nefazodone, and medicines containing cobicistat
Including people who have unexplained high liver inflammation blood tests
Vytorin may harm your unborn baby. If you become pregnant, stop taking Vytorin
Do not take: Controlled human studies show Vytorin harms baby and potential benefits do not outweigh potential harms (FDA Category X)
Do not breastfeed while taking Vytorin - either stop breastfeeding or stop Vytorin