Lack of evidence of teratogenicity of benzodiazepine drugs in Hungary.
In order to investigate possible teratogenic effects of commonly used benzodiazepines (diazepam, chlordiazepoxide, nitrazepam) in Hungary, four approaches were used: 1. A retrospective case-control study of 630 cases with isolated cleft lip +/- cleft palate, 179 cases with isolated cleft palate, 392 cases of multiple congenital anomalies including cleft lip and/or cleft palate, and their matched control cases; 2. The Case-Control Surveillance System of Congenital Anomalies in Hungary, 1980 to 1984, involving 355 cases with isolated cleft palate, 417 cases with multiple congenital anomalies, and 186 cases with Down's syndrome (as positive controls). Benzodiazepines were taken by 14.9% of 11,073 control pregnant women studied; 3. A prospective study of 33 pregnant women attending the Counselling Clinic following ingestion of benzodiazepines during the first trimester of pregnancy; 4. An observational study involving 12 pregnant women who attempted suicide and one with accidental overdosage with benzodiazepines during pregnancy. None of these four approaches gave any indication of an association between facial clefting and in utero exposure to these substances.
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Department of Human Genetics and Teratology, National Institute of Hygiene, Budapest, Hungary.
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D002707:Chlordiazepoxide / Q000009:adverse effects* / Q000506:poisoning; D003975:Diazepam / Q000009:adverse effects* / Q000506:poisoning; D005260:Female; D005817:Genetic Counseling; D006801:Humans; D006814:Hungary / Q000453:epidemiology; D009567:Nitrazepam / Q000009:adverse effects* / Q000506:poisoning; D011247:Pregnancy; D011446:Prospective Studies; D012189:Retrospective Studies
D002707:Chlordiazepoxide; D009567:Nitrazepam; D003975:Diazepam