Evaluation of bendectin embryotoxicity in nonhuman primates: II. Double-blind study in term cynomolgus monkeys.
The embryotoxic and teratogenic potential of Bendectin was assessed in this double-blind study in the cynomolgus monkey (Macaca fascicularis). Bendectin was administered orally at doses approximately two, five, and 20 times the human dose equivalent from 22 +/- 2 through 50 days of gestation. Fetuses were delivered by cesarean section near term and examined for malformations. There was no maternal toxicity as evidenced by maternal weights and physical signs. There was no correlation between dosage and the number of prenatal deaths. No significant abnormalities related to treatment were observed in postdelivery physical examinations, placental evaluations, external and internal gross examinations, or from radiographs of the neonates. Under the conditions of this study the treatment of pregnant cynomolgus monkeys with Bendectin produced no evidence of teratogenicity or embryo-, or fetal-, or maternal toxicity.
D000818:Animals; D001921:Brain / Q000187:drug effects / Q000196:embryology; D004025:Dicyclomine; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004319:Doxylamine / Q000633:toxicity*; D004338:Drug Combinations / Q000633:toxicity; D004353:Drug Evaluation, Preclinical; D005260:Female; D005333:Fetus / Q000033:anatomy & histology / Q000187:drug effects; D006801:Humans; D008252:Macaca fascicularis; D011247:Pregnancy; D011725:Pyridines / Q000633:toxicity*; D011736:Pyridoxine / Q000633:toxicity*; D013723:Teratogens / Q000633:toxicity*
D004338:Drug Combinations; D011725:Pyridines; D013723:Teratogens; C004454:dicyclomine, doxylamine, pyridoxine drug combination; D004025:Dicyclomine; D004319:Doxylamine; D011736:Pyridoxine