Pacerone and Pregnancy

If you take Pacerone during pregnancy, you may have an increased risk for miscarriage, bone defects, or other fetal harm. This pregnancy Category D medication should only be given to a pregnant woman when the benefits to the mother outweigh the potential risks to the unborn child. You may also have to wait several months after stopping treatment before it is safe to become pregnant.

Can Pregnant Women Take Pacerone?

Pacerone® (amiodarone hydrochloride) is a prescription antiarrhythmia medication used to treat people with certain types of serious abnormal heartbeats (arrhythmias). If taken during pregnancy, this medication may cause harm to your unborn child.

What Is Pregnancy Category D?

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. Pacerone is classified as a pregnancy Category D medication.
Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
In animal studies, Pacerone caused fetal defects of the skull, sternum, and toe bones when given to pregnant rats. It also decreased fetal body weights, reduced fetal growth, and increased the risk for miscarriage. When given to pregnant rabbits in doses that were 2.7 times the equivalent maximum human dose, 90 percent of the animals had a miscarriage.
Pacerone can cause a low heart rate and heart rhythm changes in newborn infants. However, these effects are usually short-term and generally did not lead to significant problems. More importantly, Pacerone has been reported to increase the risk for thyroid problems in the developing baby when taken during pregnancy, including:
It is important to note that Pacerone can stay in your body for months after you stop taking it. Therefore, if you plan to get pregnant, let your healthcare provider know you have taken Pacerone, even if you no longer take it. You will need to stop taking the drug several months before becoming pregnant to avoid any potential risks to your unborn child.
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Pacerone Medication Information

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