YOU ARE NOW CONNECTED TO THE TOXLINE (1981 FORWARD, NON-ROYALTY) FILE. ==XANAX AND PREGNANCY== 21 AUTHOR Schick-Boschetto B AUTHOR Zuber C TITLE Alprazolam exposure during early human pregnancy. SOURCE Teratology 1992 May;45(5):460 ABSTRACT We have prospectively identified 236 women exposed to alprazolam (Xanax) in therapeutic doses during the first trimester, 52 pregnancies are ongoing. Loss to follow-up rate was 12.52%. Of the known outcome, 15 women (8.15%) spontaneously aborted, 18 (9.78%) terminated the pregnancy. One hundred twenty three infants (66.84%) were reported morphologically and developmentally normal at birth. Three infants were under 2500 grams at birth, all preterm (1 set of twins, one placental abruption). Five infants (2.94%) had malformations. These included 1 unilateral cleft lip (family history of clefts), 1 hypospadias, 1 congenital hip dislocation, 1 inguinal hernia, and 1 fused lacrimal duct. This data does not suggest a significant association between alprazolam and fetal malformations. The unusually low miscarriage rate is likely due to under reporting in the non-respondants. This sample is too small to determine if alprazolam use is safe during pregnancy. Long term follow-up studies are needed before it can be determined if alprazolam effects neurobehavioral development. 17 AUTHOR St. Clair SM AUTHOR Schirmer RG TITLE First-trimester exposure to alprazolam. SOURCE Obstet Gynecol 1992 Nov;80(5):843-6 ABSTRACT OBJECTIVE: To assess prospectively pregnancy outcome associated with first-trimester exposure to alprazolam in order to monitor for early signals of potential drug-related risk to the fetus. METHODS: Reports of first-trimester exposure to alprazolam from patients, physicians, or pharmacists were registered. Information regarding drug exposure, risk factors, and pregnancy outcome was requested at 4.5 and 9 months after registration. RESULTS: From June 1982 through December 1990, 542 pregnancies had been registered. Follow-up data were obtained on 411 registrants. There were 13 live births with congenital anomalies, 263 live births with no congenital anomalies, 47 spontaneous fetal losses, and 88 elective abortions. CONCLUSIONS: No pattern of defects or excess of defects or spontaneous abortions was apparent. Although these findings may provide some reassurance in counseling women following inadvertent prenatal exposure, the cases represent a sample of insufficient size for reaching reliable and definitive conclusions about the safety of alprazolam for pregnant women and their developing fetuses. The cases accumulated in this report represent a sample of insufficient size to confirm or refute previous reports of specific congenital anomalies linked to exposure to benzodiazepines. 12 AUTHOR Johnson KA AUTHOR Jones KL AUTHOR Chambers CD AUTHOR Dick L AUTHOR Felix R TITLE Pregnancy outcome in women exposed to non-valium benzodiazepines. SOURCE Teratology 1995 Mar;51(3):170 ABSTRACT Although Valium has been studied extensively regarding its effect on the unborn, little is known regarding the teratogenicity of the other benzodiazepines. The purpose of this report is to document pregnancy outcomes in 252 women who contacted the California Teratogen Information Service during early pregnancy regarding their concern about the effect of one of the non-Valium benzodiazepines. Included were 135 women who took Xanax, 58 who took Klonopin and 23 who took Ativan as well as 46 women who took 1 of 7 other agents. Of the 252 women who were initially ascertained, there were 166 liveborns (66%), 30 (12%) SAB's, 1 (.04%) stillbirth, 20 (8%) TAB's and 35 (14%) who were lost to follow-up. Of the 88 liveborn infants prenatally exposed to Xanax, there were 3 major malformations; one had a tracheo-esophageal fistula, and 2 infants had bilateral inguinal hernias. Of the 38 liveborn infants prenatally exposed to Klonopin, there were 3 (8%) with major malformations; one had an undescended testicle that required orchidopexy at 4 years of age, one had bilateral inguinal hernia, and one had a ventricular septal defect and a unilateral inguinal hernia. The latter patient was prenatally exposed to phenobarbital and Tegretol in addition to Klonopin. The presence of 4 prenatally exposed infants with inguinal hernias may well be significant. It is tempting to speculate that the muscle relaxant effect of these agents may play a role in the pathogenesis of hernia formation. 9 AUTHOR Goldberg HL TITLE Psychotropic drugs in pregnancy and lactation. SOURCE Int J Psychiatry Med 1994;24(2):129-47 ABSTRACT OBJECTIVE: This article reviews the literature on the use of psychotropic drugs in pregnancy and lactation. METHOD: Medline search yielded more than five hundred titles. Articles were reviewed and ninety-one were selected for reference. RESULTS: Fetal physiology and teratogenicity are discussed and the effects of specific drugs on the fetus and newborn are presented. When possible, recommendations for use or non-use are presented. CONCLUSIONS: Though no controlled studies have ever been done in pregnant women to truly prove their safety, it appears that most, but not all, current psychotropic drugs appear fairly safe for use in pregnancy.