Association between cleft lip with or without cleft palate and prenatal exposure to diazepam.

From 278 interviews of women who had infants with selected major malformations, a history of diazepam ingestion in the first trimester of pregnancy was found to be four times more frequent among mothers of children with a cleft lip with or without a cleft palate than among mothers of children with other defects. This association was one of many that was examined in the analysis; thus it is quite possible that it is simply due to chance. This report, however, is the second one linking diazepam to cleft lip with or without cleft palate. Until there are more data bearing on this question, this possible risk should be considered when prescribing diazepam for women in their reproductive years.