Collaborative ENTIS study of the fetal effects of maternal varenicline use in pregnancy

s / Reproductive Toxicology 60 (2016) 172–187 175 Teratology Information, Training and Research Center) for a risk assessment regarding TCC exposure during pregnancy. Methods: A search through all prospectively recorded referrals with an exposure to TCC during pregnancy between the years 2009–2014 in our records retrieved the data of forty-eight pregnant women. Information regarding pregnancy outcomes was collected through structured telephone interviews with mothers/families. Results: Of 48 pregnancies, the majority of the exposures (91.7%) occurred during the first trimester with a mean maternal gestational age at admission of 8.3 ± 3.3 weeks. The median daily dose of TCC was 8 mg/d and the duration of exposure varied between 1 and 49 days. The route of administration was oral in 32, intramuscular in 11 and was unknown in 5 of the pregnant women respectively. Of the 43 pregnancies with known outcomes, 32 (74.4%) were live births, 4 (9.3%) were spontaneous abortions and 7 (16.3%) were elective abortions. There were 2 major (6.4%) (a cleft lip with palate and a bilateral hip dislocation) and 1 minor (3.1%) (vesicoureteral-renal reflux) congenital malformations and twenty-nine (90.6%) normal outcomes in live births. Among the infants with normal outcomes at birth, one infant was diagnosed with unilateral hydronephrosis at 6 months and another infant with immunodeficiency 1.5 years after the delivery, respectively. Conclusions: The collective evaluation with our results with the previously reported case series, which included the outcomes of 41 and 18 pregnancies following TCC exposure, suggest that inadvertent exposure to TCC during early pregnancy is unlikely to be associated with a substantial embryotoxicity. Although these results may offer some value to clinicians for counseling the pregnant women with inadvertent TCC exposure, the lack of a control group and small number of cases preclude further conclusions. We suggest the continuation of the restriction of TCC use in pregnant women and increasing the surveillance regarding TCC exposure during pregnancy to ascertain further outcomes. http://dx.doi.org/10.1016/j.reprotox.2016.03.012 Opipramol for antidepressant therapy in early pregnancy