Birth defects related to bendectin use in pregnancy. I. Oral clefts and cardiac defects
Mitchell, A.A.; Rosenberg, L.; Shapiro, S.; Slone, D.
JAMA 245(22): 2311-2314
1981
ISSN/ISBN: 0098-7484 PMID: 7230459 Document Number: 179158
The risks of birth defects previously associated with Bendectin use in early pregnancy were evaluated in a case-control study of malformed human infants whose mothers were interviewed in 3 regional centers; 98 infants with isolated cleft palate (CP), 221 with cleft lip with or without cleft palate (CL .+-. CP) and 122 with selected heart defects (HD) were compared to 970 other malformed infants who served as controls. Relative risk estimates (with their 95% confidence limits) for 1st-trimester exposure to Bendectin were as follows: CP, 0.9 (0.5-1.5); CL .+-. CP, 0.6 (0.4-0.8); HD, 1.0 (0.6-1.6). Allowance for a large number of potentially confounding factors did not materially influence the risk estimates. Apparently, in utero exposure to Bendectin does not appreciably increase the risk of oral clefts or selected cardiac defects.