Bendectin and human congenital malformations.
The relationship between Bendectin exposure during the first trimester of pregnancy and the occurrence of congenital malformations was prospectively studied in 31,564 newborns registered in the Northern California Kaiser Permanente Birth Defects Study. The odds ratio for any major malformation and Bendectin use was 1.0 (95% confidence interval 0.8-1.4). There were 58 categories of congenital malformations; three of them were statistically associated with Bendectin exposure (microcephaly--odds ratio = 5.3, 95% confidence interval = 1.8-15.6; congenital cataract--odds ratio = 5.3, 95% confidence interval = 1.2-24.3; lung malformations (ICD-8 codes 484.4-484.8)--odds ratio = 4.6, 95% confidence interval = 1.9-10.9). This is exactly the number of associations that would be expected by chance. An independent study (the Collaborative Perinatal Project) was used to determine whether vomiting during pregnancy in the absence of Bendectin use was associated with these three malformations. Two of the three (microcephaly and cataract) had strong positive associations with vomiting in the absence of Bendectin use. We conclude that there is no increase in the overall rate of major malformations after exposure to Bendectin and that the three associations found between Bendectin and individual malformations are unlikely to be causal.
Shiono
P H
PH
National Institute of Child Health and Human Development, Prevention Research Program, Bethesda, Maryland 20892.
Klebanoff
M A
MA
D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D002490:Central Nervous System / Q000002:abnormalities; D004025:Dicyclomine; D004065:Digestive System Abnormalities; D004319:Doxylamine / Q000009:adverse effects*; D004338:Drug Combinations / Q000009:adverse effects; D005260:Female; D006257:Head / Q000002:abnormalities; D006330:Heart Defects, Congenital / Q000139:chemically induced; D006801:Humans; D008168:Lung / Q000002:abnormalities; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D011446:Prospective Studies; D011725:Pyridines / Q000009:adverse effects*; D011736:Pyridoxine / Q000009:adverse effects*; D014564:Urogenital Abnormalities; D014839:Vomiting
D004338:Drug Combinations; D011725:Pyridines; C004454:dicyclomine, doxylamine, pyridoxine drug combination; D004025:Dicyclomine; D004319:Doxylamine; D011736:Pyridoxine