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Rythmol SR and Pregnancy

As a pregnancy Category C medicine, Rythmol SR (propafenone SR) should only be given to a pregnant woman if the benefits to the mother outweigh the potential risks to the unborn child. When given to pregnant animals, the medication appeared to increase the risk for miscarriage and decreased offspring survival.

Can Pregnant Women Take Rythmol SR?

Rythmol SR® (propafenone SR) is a prescription medication approved to treat an abnormal heart rhythm known as atrial fibrillation. This drug may not be safe for use during pregnancy, although the full risks are currently unknown.

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 SR 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.
Rythmol SR has not been adequately studied in pregnant humans. In animal studies, the medication did not cause birth defects when given to pregnant rats and rabbits. However, it did decrease offspring survival when given in high doses to pregnant rats and rabbits. It also increased the risk for miscarriage in pregnant rabbits at lower doses.
However, animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine, including Rythmol SR, 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.
Pregnancy and Pain

Rythmol SR Drug Information

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