Tambocor and Pregnancy

As a pregnancy Category C medication, Tambocor (flecainide) may not be safe for pregnant women to take. Although insufficient studies have been done in women, the medication has been shown to cause birth defects 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 Tambocor?

Tambocor™ (flecainide acetate) is a prescription antiarrhythmia medication. Based on animal studies, this drug may not be safe for use in pregnant women. However, the medication is sometimes used off-label in the third trimester to treat abnormal heartbeats in the fetus.
 

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. Tambocor 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.
 
In animal studies, Tambocor caused birth defects when given to a particular breed of pregnant rabbits at about four times the normal human dose. Some of these birth defects included:
 
  • Heart defects
  • Club paws
  • Defects of the sternum and vertebrae.
 
Similar problems were not seen in studies using a different breed of rabbits. However, the drug delayed sternum and vertebrae bone development in rat fetuses when given to pregnant rats.
 
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.
 
This medication has not been adequately studied in pregnant women. Tambocor is sometimes given to women in the third trimester of pregnancy to treat fetal arrhythmias (abnormal heart rhythms in the fetus). When used in this way, the medication appears to be associated with very little risk to the fetus.
 
However, there have been reports of the fetus developing potential Tambocor side effects, such as hyperbilirubinemia (jaundice). It is unknown whether Tambocor is safe for use earlier in pregnancy, as there is very little information about the use of the medication in the first trimester.
 
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