Debendox revisited.

ABSTRACT

Two further studies re-examine the findings by Golding et al. (1983) in Oxford that mothers of children born with oral clefts had been more frequently prescribed Debendox (Bendectin) than had the mothers of matched controls. In Cardiff, 86 283 total births between 1965 and 1979 included 139 infants with oral clefts. Detailed information was obtained about 93 of these infants and matched controls. The relative risk of the birth of an infant with an oral cleft to women prescribed Debendox within 69 days of the first day of their last menstrual period was 0.64 (95% confidence limits 0.12-3.34). No increased effect was found amongst women who smoked. In Aberdeen, 17 640 livebirths between 1976 and 1979 included 31 children with oral clefts. Compared with the non-exposed group the risk of a birth of an infant with an oral cleft to a woman prescribed Debendox in early pregnancy was 0.37 (95% confidence limits 0.09-1.47). These results do not confirm the previous findings in Oxford of a possible association between exposure to Debendox in early pregnancy and the occurrence of oral clefts in the child.