Nexterone and Pregnancy

As a pregnancy Category D medication, Nexterone (amiodarone premixed injection) may cause fetal harm if used during pregnancy. Nexterone has been shown to cause decreased fetal body weights, miscarriages, and birth defects when given to pregnant animals. However, there may be situations when the benefits of using the drug outweigh the possible risks.

Can Pregnant Women Use Nexterone?

Nexterone® (amiodarone premixed injection) is a prescription medication given as an injection into a vein in people who are having life-threatening, abnormal heartbeats (arrhythmias). This medication may cause harm to an unborn child if given to a pregnant woman.

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 specific medicine is taken during pregnancy. Nexterone 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 the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
In animal studies, Nexterone caused a variety of problems when given to pregnant rats, including:
  • Defects of the skull, sternum, and toe bones
  • Decreased fetal body weights
  • Impaired fetal growth
  • Increased risk for miscarriage.
When given to pregnant rabbits in doses that were 2.7 times the maximum human dose, the drug caused miscarriage in 90 percent of the animals.
Nexterone can cause a low heart rate and heart rhythm changes in newborn infants. However, these effects are usually short-term, and are not expected to lead to significant problems.
More importantly, amiodarone (the active ingredient in Nexterone) has been reported to increase the risk for thyroid problems in the developing fetus when used during pregnancy. Problems have included:
Nexterone is used to treat life-threatening arrhythmias. Therefore, it may still be used during pregnancy if a healthcare provider believes the potential benefits to a pregnant woman outweigh any potential risks to her unborn baby.
Nexterone stays in the body for months; therefore, any potential risks to an unborn child will persist even after the medicine is stopped. If you plan to get pregnant, let your healthcare provider know you have received Nexterone, even if you are no longer using the medication. You will need to stop using Nexterone several months before becoming pregnant to avoid any potential risks to your unborn child.
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Nexterone Medication Information

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