Simcor and Pregnancy
It is recommended that pregnant women avoid Simcor (niacin extended-release/simvastatin). The FDA has classifed the drug as a pregnancy Category X medication, which means that it could cause problems in the fetus. If pregnancy occurs while you are taking Simcor, notify your healthcare provider immediately to discuss the potential risks.
Simcor® (niacin extended-release/simvastatin) is a pregnancy Category X medicine. This means that it could potentially cause harm to an unborn child. Pregnant women should not take Simcor. If you are pregnant or thinking about becoming pregnant, talk to your healthcare provider immediately.
Simcor contains two different medications, extended-release niacin (Niaspan®) and simvastatin (Zocor®). Simcor received a pregnancy Category X rating due to the simvastatin component.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when specific medicines are taken during pregnancy. Category X is given to medicines that show problems to the fetus in pregnant animal studies or in humans who have taken the medicine while pregnant. It is not recommended to use a Category X medicine during pregnancy.
Animal studies do not indicate that simvastatin increases the risk of birth defects. There have been occasional reports of problems (such as miscarriages or birth defects) in humans, but it does not appear that simvastatin actually increases the risks of such problems (a certain number of miscarriages and birth defects will occur during pregnancies, even if no medications are taken).
The effects of high cholesterol do not cause problems for many years (or even decades). Therefore, it should be expected that if a woman does not take cholesterol medicine during pregnancy, it will have little impact on any long-term risks. Since there is little benefit and a very real risk during pregnancy, your healthcare provider will likely recommend that you do not take Simcor while pregnant. For women who are thinking of becoming pregnant and are taking Simcor, please make sure that you discuss Simcor and pregnancy with your healthcare provider.