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As a pregnancy Category C medication, Tikosyn (dofetilide) may not be safe for use in pregnant women. Although it has not been studied in pregnant women, Tikosyn has been shown to cause miscarriages and numerous birth defects when used in animal studies. However, there may be times when the benefits of the drug outweigh the possible risks to the unborn child.
Can Pregnant Women Take Tikosyn?Tikosyn® (dofetilide) is a prescription medication approved to treat people with atrial fibrillation or atrial flutter, types of abnormal heart rhythms. It belongs to a class of medicines known as antiarrhythmics. Based on animal studies, this drug may not be safe for use in pregnant women.
What Is Pregnancy Category C?The 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. Tikosyn is classified as a pregnancy Category C medication.
Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause fetal harm in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Tikosyn has not been studied in pregnant women. However, in animal studies, the drug was shown to impair fetal growth and cause miscarriages when given to pregnant rats and mice. It also increased the risk for bone defects in the baby mice and rats, including abnormalities of the sternum and vertebrae. When given in very high doses to pregnant rats, Tikosyn caused other problems in the rat offspring, including cleft palate, missing fingers and toes, and heart defects.
It is important to note, however, 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.