Periconceptional Exposure to Efavirenz and Neural Tube Defects [De Santis M et al. Arch Intern Med 2002;162:355] This is a report from Italy of a case in which a woman conceived during treatment with efavirenz and the pregnancy resulted in myelomeningocele, which represents a fetal neural tube defect.
Comment: Efavirenz is the only antiretroviral drug that was tested in non-human primates in teratology studies. This work showed that three of 20 pregnant monkeys (15%) produced malformations consisting of anencephaly, microphthalmia and cleft palate. As a result, the supplier recommends that women avoid efavirenz during pregnancy, and this is also a recommendation of the DHHS guidelines on use of antiretroviral drugs in adults and adolescents. Nevertheless, the FDA has given it a category C, in part based on the fact that no other antiretroviral drug has been tested in monkeys. The report here is clearly anecdotal, but the authors point out that myelomeningoceles are congenital anomalies (neural tube defects) similar to anencephaly reported in monkeys and possibly reflect efavirenz exposure during the period of neural tube closure. A similar case was reported by C. Fundaro and colleagues [AIDS 2002;16:299], but this appears to be the same case.
posted 2/20/2002

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