The effects of benzodiazepines in pregnancy.
OBJECTIVE
The objectives of the study were to assess the prevalence of anxiolytic use in pregnancy, the rate of congenital malformations in neonates at in utero exposure to these agents, and the possible association of congenital malformations with the use of these drugs in pregnancy.


METHODS
The study was conducted as cross-sectional study. The study was performed at university departments of gynecology and obstetrics in four Zagreb hospitals and included 893 pregnant women. Main outcome measures were pathological defects and congenital malformations.


RESULTS
The main anatomic group N drugs (nervous system) was predominated by the use of the benzodiazepine anxiolytic diazepam (FDA group D), which increased with gestational age. Diazepam was used by 74 (8.3%), 127 (14.2%) and 212 (23.7%) women in the first, second and third trimester respectively. Diazepam ranked second among twenty most frequently prescribed drugs in pregnancy. It was taken by 303 (33.9%) pregnant women, while congenital cardiovascular malformations were recorded in three children and genitourinary malformations in three children too.


CONCLUSIONS
The high utilization of diazepam in pregnancy that is not supported by professional guidelines is an issue of serious concern. In spite of some study limitations, its results pointed to inappropriate and even potentially harmful use of drugs in pregnant women from Zagreb, thus calling for upgrading the quality of therapy in this vulnerable period of life. In our opinion, other measures appear to be a more appropriate therapeutic modality than medicamentous therapy in many cases.
Leppée
Marcel
M
Department of Pharmacoepidemiology, Andrija Stampar Institute of Public Health, 10000 Zagreb, Croatia. marcel.leppee@stampar.hr
Culig
Josip
J
Eric
Mirela
M
Sijanovic
Sinisa
S
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D014151:Anti-Anxiety Agents / Q000009:adverse effects*; D001007:Anxiety / Q000188:drug therapy; D002318:Cardiovascular Diseases / Q000139:chemically induced; D003975:Diazepam / Q000009:adverse effects*; D005260:Female; D005865:Gestational Age; D006801:Humans; D011247:Pregnancy / Q000187:drug effects*; D013272:Stomach Diseases / Q000139:chemically induced
D014151:Anti-Anxiety Agents; D003975:Diazepam