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In animal studies involving Tiazac and pregnancy, the medication increased the risk of miscarriages and birth defects when it was given to pregnant rabbits, mice, and rats. As a result, the FDA has classified Tiazac as a pregnancy Category C medication. However, a pregnant woman may take Tiazac if her healthcare provider decides that the benefits outweigh the potential risks.
Is Tiazac Safe During Pregnancy?Tiazac® (diltiazem hydrochloride) may not be safe for pregnant women. This is based on animal studies that looked at the effects of the drug during pregnancy.
Tiazac and Pregnancy Category CThe U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Tiazac was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant rabbits, mice, and rats, the drug increased the risk of miscarriages and birth defects (especially skeletal problems).
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.