Bendectin and birth defects: I. A meta‐analysis of the epidemiologic studies

Abstract “Bendectin” Bendectin is the US trademark for a combination of doxylamine and dicyclomine used for the treatment of nausea and vomiting of pregnancy. Prior to 1977, it also contained pyridoxine. Analogous products were distributed in the United Kingdom under the trademark “Debendox” and in Germany under the trademark “Lenotan.” (Doxylamine/Dicyclomine/Pyridoxine) was widely used for the treatment of nausea and vomiting of pregnancy until 1983, when production was discontinued in the face of lawsuits alleging that the drug caused congenital malformations. We have conducted a meta‐analysis of the 16 cohort and 11 case‐control studies that report birth defects from Bendectin‐exposed pregnancies. This meta‐analysis provides an estimate of the relative risk of malformation at birth in association with Bendectin exposure. The pooled estimate of the relative risk of any malformation at birth in association with exposure to Bendectin in the first trimester was 0. 95 (95% Cl 0. 88 to 1. 04). Separate analyses were undertaken for cardiac defects, central nervous system defects, neural tube defects, limb reductions, oral clefts, and genital tract malformations. In these categories, the pooled estimates of relative risk ranged from 0. 81 for oral clefts to 1. 11 for limb reductions, with all 95% confidence intervals enclosing unity. With the exception of studies for oral clefts and for pyloristenosis, tests for heterogeneity of association indicated for each table that all studies were estimating the same odds ratio. These studies, as a group, showed no difference in the risk of birth defects between those infants whose mothers had taken Bendectin during the first trimester of pregnancy and those infants whose mothers had not. It is unlikely that Bendectin exposure contributed to the prevalence of congenital malformations in the population.© 1994 Wiley‐Liss, Inc.