Heart Home > Cordarone and Pregnancy

There are potentially serious complications that may occur if Cordarone is taken during pregnancy. Women who are undergoing treatment with this drug should be aware that this pregnancy Category D medication was shown to cause miscarriages, birth defects, and other problems when given to pregnant animals. Also, this drug can stay in your body for months after taking it.

Can Pregnant Women Take Cordarone?

Cordarone® (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. Cordarone 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.
When given to pregnant rats, Cordarone caused problems with the skull, sternum, and toe bones in the developing rats. It also decreased fetal body weights, negatively affected 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, the drug caused miscarriage in 90 percent of the animals.
Cordarone can cause a low heart rate and heart rhythm changes in newborn infants. However, these effects are usually short-term and normally do not lead to significant problems. More importantly, Cordarone has been reported to increase the risk for thyroid problems in the developing baby when taken during pregnancy, including:
You should know that Cordarone 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 Cordarone, even if you no longer take the medication. You will need to stop taking the medication several months before becoming pregnant to avoid any potential risks to your unborn child.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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