Bendectin (Debendox) as a risk factor for pyloric stenosis.
The maternal use of Bendectin (Debendox) in the first trimester of pregnancy was examined in a case-control (n = 1,427 and 3,001, respectively) study of malformed infants whose mothers were interviewed between 1974 and 1976. Mothers of infants with congenital malformation showed an increased likelihood (odds ratio = 1.40) of having used Bendectin, with a stronger association of Bendectin with birth defects for mothers who also smoked (odds ratio = 2.91). A significant association was observed between the occurrence of pyloric stenosis in the infant and exposure to Bendectin in utero (odds ratio = 4.33). When maternal sociodemographic factors, including smoking, and smoking alone, were controlled, the association between Bendectin and pyloric stenosis was further increased (odds ratio = 4.63 and 5.24, respectively). Except for a possible association of Bendectin with heart valve anomalies (odds ratio = 2.99), we were unable to document other significantly increased risks for congenital malformations.
D000014:Abnormalities, Drug-Induced / Q000209:etiology; D000328:Adult; D004025:Dicyclomine; D004319:Doxylamine / Q000009:adverse effects*; D004338:Drug Combinations / Q000009:adverse effects; D005260:Female; D006330:Heart Defects, Congenital / Q000139:chemically induced; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008431:Maternal-Fetal Exchange; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D011707:Pyloric Stenosis / Q000139:chemically induced*; D011725:Pyridines / Q000009:adverse effects*; D011736:Pyridoxine / Q000009:adverse effects*; D012306:Risk; D012907:Smoking
D004338:Drug Combinations; D011725:Pyridines; C004454:dicyclomine, doxylamine, pyridoxine drug combination; D004025:Dicyclomine; D004319:Doxylamine; D011736:Pyridoxine