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Efavirenz Pregnancy and Breastfeeding Warnings

Efavirenz is also known as: Sustiva

Efavirenz Pregnancy Warnings

Animal studies have revealed evidence of fetal harm. Efavirenz crosses the placenta in animals and produces fetal blood levels similar to maternal blood levels. Efavirenz may cause fetal harm when used during the first trimester. There are no controlled data in human pregnancy. To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to prospectively register patients. Information is available at As of July 2010, the APR had received prospective reports of 792 pregnancies, 718 of which were first trimester exposures. Birth defects occurred in 17 of 604 live births with first trimester exposure and 2 of 69 live births with second or third trimester exposure. One of these prospective reports with first trimester exposure was a neural tube defect. Also, a single case of anophthalmia has been prospectively reported with first trimester exposure; however, this case included severe oblique facial clefts and amniotic banding, a known association with anophthalmia. There have been 6 cases of findings consistent with neural tube defects (including meningomyelocele) retrospectively reported in infants of mothers who had first trimester exposure. Multiple defects (Dandy-Walker syndrome) in a fetus from a spontaneous abortion and neural tube defects in a fetus from a pregnancy terminated during the second trimester have also been reported. Both mothers had first trimester exposure to efavirenz-containing regimens. Causality could not be clearly established in any of these cases. The manufacturer recommends avoiding pregnancy during efavirenz therapy. Barrier contraception must always be used in combination with other methods of contraception (e.g., hormonal) during efavirenz therapy. Use of adequate contraception for 12 weeks after efavirenz discontinuation is recommended. Women of childbearing age should undergo pregnancy testing before starting efavirenz therapy and should be advised to notify their physician if they become pregnant during therapy. Patients should be advised of the potential harm to the fetus if they become pregnant while taking efavirenz or if it is used during the first trimester. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: D Efavirenz should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus. Comments: Effective contraception is recommended during therapy and for 12 weeks after the drug is stopped.

Efavirenz Breastfeeding Warnings

Breast-feeding is not recommended during use of efavirenz. Excreted into human milk: Unknown Excreted into animal milk: Yes The US Centers for Disease Control and Prevention and the American Academy of Pediatrics advise HIV-infected women not to breast-feed to avoid postnatal transmission of HIV to a child who may not yet be infected.

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