Neural tube defects linked to efavirenz (Sustiva)

According to the U.S. Food and Drug Administration (FDA), the prescribing information for efavirenz (Sustiva) has been changed to include new information. Efavirenz is an antiretroviral drug for treatment of acquired immune deficiency syndrome (AIDS). The FDA has received four reports of neural tube defects in infants born to mothers with first trimester exposure to efavirenz. These defects included three cases of myelomeningocele and one case of Dandy Walker malformation. Women who are taking efavirenz are cautioned against becoming pregnant because of the risk of these neural tube defects occurring.