Ziagen and Pregnancy

The FDA has classified Ziagen as a pregnancy Category C medication because the medication has not been adequately studied in pregnant women. In animal studies involving Ziagen and pregnancy, high doses of Ziagen were given to rats and caused an increased risk of birth defects, miscarriages, stillbirths, and developmental problems. However, a healthcare provider may prescribe Ziagen to a pregnant woman if the benefits outweigh the risks.

 

Ziagen and Pregnancy: An Overview

Ziagen® (abacavir sulfate) is a prescription HIV treatment. Because it has not been adequately studied in pregnant women, it is not known if Ziagen is safe for use during pregnancy. However, in some circumstances, the benefits of Ziagen may outweigh the potential risks.
 

Ziagen and Pregnancy Category C

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 done on Ziagen in pregnant woman, Ziagen has been studied in pregnant animals.
 
Ziagen has been studied in pregnant rats and rabbits. A very high Ziagen dosage given to pregnant rats increased the risk of birth defects, miscarriages, stillbirths, and developmental problems (such as low fetal weights and slower fetal development). No similar problems were seen when Ziagen was given to pregnant rabbits.
 

Ziagen and Pregnancy: Final Thoughts

If you are pregnant, it is always a good idea to ask your healthcare provider before taking any medication. You and your healthcare provider can consider the possible risks and benefits of using Ziagen in your particular situation, as well as any other treatment alternatives. Women with HIV need special prenatal care, both for themselves and to prevent the transmission of HIV to their babies.
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;