Epzicom and Pregnancy: An Overview

Epzicom™ (abacavir/lamivudine) is a prescription HIV treatment. It contains two different medications in one tablet. Because it has not been adequately studied in pregnant women, Epzicom may not be safe for use during pregnancy. However, in some circumstances, the benefits of Epzicom may outweigh the potential risks.

 

The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating. While there have been no adequate studies of Epzicom in pregnant woman or animals, the individual components of Epzicom have been studied in pregnant animals.

 

Abacavir has been studied in pregnant rats and rabbits. Very high abacavir dosages increased the risk of birth defects, miscarriages, stillbirths, and developmental problems (such as low fetal weight and slower fetal development) when it was given to pregnant rats. No similar problems were seen when abacavir was given to pregnant rabbits.

 

In studies, giving lamivudine to pregnant rabbits appeared to increase the risk of early miscarriages, although this was not seen in studies involving rats. In either rats or rabbits, lamivudine did not seem to increase the risk of birth defects. In general, case reports of lamivudine use in pregnant women suggest that it is probably safe for use in pregnancy.