Efavirenz Pregnancy and Breast Feeding Warnings
Efavirenz is also known as: Sustiva
Overview
Efavirenz may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Efavirenz while you are pregnant. It is not known if Efavirenz is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Efavirenz to the baby.
Efavirenz Pregnancy Warnings
Efavirenz has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of fetal harm. There are no controlled data in human pregnancy. Efavirenz is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
Efavirenz may cause fetal harm when administered during the first trimester. Efavirenz crosses the placenta in animals and produces fetal blood concentrations similar to maternal blood concentrations. Reproduction studies in monkeys given dosages yielding plasma drug concentrations similar to those in humans treated with normally recommended dosages have revealed evidence of teratogenicity, including anencephaly, unilateral anophthalmia, microphthalmia, and cleft palate. Increased fetal resorptions were reported in rats and no reproductive toxicity was reported in rabbits. As of July 2007, the Antiretroviral Pregnancy Registry has received reports of 373 pregnancies, 359 of which were first trimester exposures. Birth defects were observed in 7 of 295 live births with first trimester exposure and 1 of 26 live births with second or third trimester exposure, none of which were neural tube defects. In addition, 5 cases of findings consistent with neural tube defects have been 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 treatment with efavirenz. Barrier contraception should be used in combination with other methods of contraception (e.g., hormonal). Women of childbearing age should undergo pregnancy testing before initiating efavirenz therapy and be advised to notify their physician if they become pregnant during treatment. Patients should be advised of the potential harm to the fetus if they become pregnant while taking efavirenz or if it is administered during the first trimester. An Antiretroviral Pregnancy Registry has been established to monitor maternal-fetal outcome of efavirenz exposures during pregnancy. To register patients, physicians may call 800-258-4263 (USA).
Efavirenz Lactation Warnings
There are no data on the excretion of efavirenz into human milk. HIV-infected mothers should not breast-feed their infants due to the risk of transmission of HIV via breast milk.
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