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In clinical studies on Sustiva and pregnancy, the medication caused serious birth defects when it was given to pregnant monkeys. Some studies also suggest that the drug may increase the risk of birth defects in humans. Due to these potential complications, Sustiva is generally not recommended for pregnant women. If you are taking Sustiva and pregnancy occurs, notify your healthcare provider immediately.
Sustiva® (efavirenz) is a prescription HIV treatment. Based on problems in animal studies and reports of problems in humans, Sustiva may not be safe for use during pregnancy.
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 may still offer benefits that outweigh the risks. A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
Giving Sustiva to pregnant monkeys increased the risk of serious birth defects. Studies in humans have also suggested an increased risk of birth defects, although more thorough studies are needed before the full risks are known.
Currently, it is recommended that all women able to have children should have a pregnancy test before starting Sustiva (and should not take Sustiva if a pregnancy is detected). Women should always use a barrier method of contraception (such as condoms), even if they use another form of birth control, such as birth control pills. At this time, it is not known if Sustiva affects hormonal contraceptives (such as birth control pills, patches, rings, or injections). It is recommended that women continue to use birth control for 12 weeks after stopping Sustiva, since it takes quite a while for the medication to leave the bloodstream.