Heart Home > Rythmol and Pregnancy
Because Rythmol (propafenone) is a pregnancy Category C medication, it may not be safe for use in pregnant women. Even though research has not been done in humans, Rythmol has been shown to cause decreased fetal survival when given to pregnant animals. However, there may be situations when the benefits of using the drug outweigh the possible risks to the unborn child.
Can Pregnant Women Take Rythmol?Rythmol® (propafenone) is a prescription medication approved to treat certain abnormal heart rhythms (heart arrhythmias). 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. Rythmol 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.
Rythmol did not cause birth defects when given to pregnant rats and rabbits. However, in high doses (about three times the maximum recommended human dose), the drug decreased survival in the rat offspring. It also decreased fetal survival when given to pregnant rabbits in low and high doses. Rythmol has not been adequately studied in pregnant women.
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.