Combivir and Pregnancy

While no specific studies have been done on Combivir and pregnancy, the individual components of the drug (lamivudine and zidovudine) have been studied. Overall, results indicate that these medications (and therefore Combivir) are safe for use during pregnancy, although the full risks are not known. If you are taking Combivir and pregnancy occurs, your healthcare provider will consider the benefits and risks in your particular situation.

 

Combivir and Pregnancy: An Overview

Combivir® (lamivudine/zidovudine) is a prescription HIV medication. It may not be safe for use during pregnancy, although in some circumstances, the benefits of Combivir may outweigh the potential risks.
 

Combivir and 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. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that 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 Combivir in pregnant woman or animals, the individual components of the drug have been studied in pregnant animals, and zidovudine has been studied in pregnant humans.
 
Zidovudine and Pregnancy: Is There a Risk?
In one study, when zidovudine was given to pregnant rats, it increased the risk of miscarriages, but did not seem to increase the risk of birth defects. However, another study suggested that very high doses of zidovudine may cause birth defects in rats. In general, animal studies show that zidovudine is probably safe for use in pregnancy, although there is some evidence that it may affect fertility and early pregnancy development.
 
Zidovudine has also been studied in pregnant women. In fact, it is approved to be used during pregnancy to help prevent the transmission of the HIV virus to the baby. In one study, zidovudine reduced the risk of HIV infection in the newborns by up to 86.7 percent. These studies showed that zidovudine generally did not increase the risk of birth defects or other problems.
(Combivir and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;