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In clinical studies on Atripla and pregnancy, the efavirenz component of the medication increased the risk of birth defects when it was given to pregnant monkeys. Since Atripla may present risks to an unborn child, healthcare providers should only prescribe the drug to pregnant women if the benefits outweigh the possible risks. If you are taking Atripla and pregnancy occurs, contact your healthcare provider immediately.
Atripla™ (efavirenz, emtricitabine, and tenofovir disoproxil fumarate) is a prescription HIV treatment. Based on information from animal studies, the drug may not be safe for use during pregnancy, although the benefits of Atripla may outweigh the risks for many women.
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 D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but that may still offer benefits that outweigh the risks that the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh the risks to the unborn child.
Atripla was given a pregnancy Category D rating due to the efavirenz component of it. Giving efavirenz to pregnant monkeys increased the risk of serious birth defects. Studies in humans have also suggested an increased risk of birth defects due to efavirenz, although more thorough studies are needed before the full risks are known. Neither of the other two active ingredients (emtricitabine and tenofovir) has been shown to cause any problems during pregnancy.
Women should be given a pregnancy test before starting Atripla. In addition, adequate contraception (in order to avoid pregnancy) should be used while a woman is taking Atripla and for 12 weeks after stopping the medication. Adequate contraception must include a barrier method (such as condoms), as hormonal birth control methods (such as birth control pills) may be made less effective by Atripla.