Disopyramide and Pregnancy

Because it is a pregnancy Category C medicine, disopyramide is usually only given to a pregnant woman if the benefits to the mother outweigh the potential risks to the fetus. During animal studies, disopyramide appeared to decrease the growth and survival of the offspring. Due to these potential risks, pregnant women should talk to their healthcare provider before starting this medicine.

Can Pregnant Women Take Disopyramide?

Disopyramide (Norpace®, Norpace® CR) is a prescription medication used in the treatment of serious heart rhythm problems. Although the medication does not cure an arrhythmia, it can help control it and prevent future episodes. Based on animal studies, this drug may not be safe for use during pregnancy.

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. Disopyramide is classified as a pregnancy Category C medication.
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but do appear to cause fetal harm in animal studies. In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
In animal studies, disopyramide decreased the growth and survival of rat offspring when given in high doses to pregnant rats. It should be noted that the doses given were high enough to also cause problems in the pregnant rats, including reduced feeding and difficulty gaining weight.
However, animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine, including disopyramide, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
Disopyramide has not been adequately studied in pregnant humans. There are several cases of women who used the medication throughout pregnancy without any subsequent birth defects or other problems occurring in the fetus. However, the medicine has also been reported to cause uterine contractions and early onset of labor when taken by pregnant women.
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Disopyramide Drug Information

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