[Neonatal consequences of benzodiazepines used during the last month of pregnancy].
BACKGROUND
Since benzodiazepines (BZD) are largely prescribed during pregnancy, the Regional Pharmacovigilance Center (RPVC) of Tours regularly deals with questions about the risk of their administration to pregnant women and the monitoring of the newborns exposed in utero to these drugs. During the third trimester, we recommend a switch in the BZD maternal treatment to oxazepam, which has an intermediary half-life and no active metabolite, and a hospitalisation of the newborn in order to monitor his respiratory rate. The purpose of our study was to evaluate the neonatal consequences of BZD used at the end of pregnancy and to analysed if our recommendations were taken into account and if they were appropriate.


METHODS
From 1989 to the end of 2002, we studied the files in which women had received a BZD during the 30 days prior to delivery. We analysed maternal treatments, the outcome of pregnancy and the development of the newborn, the therapeutically attitude recommended and whether or not it was respected.


RESULTS
A total of 73 files were selected. Seventy neonates were born to 73 women. The newborns were hospitalised (73%) and they developed adverse reactions possibly related to the use of BZD (51,5%) : an impregnation syndrome (42%) characterized by hypotonia and hypoventilation, and a withdrawal syndrome (20%) with tremulations as the main symptom.


CONCLUSIONS
Considering the most frequent neonatal manifestations, hospitalization and the respiratory monitoring recommended by the RPVC seemed adequate. However, the switch to oxazepam was seldom done and its advantages should be pointed out.
Swortfiguer
D
D
Centre régional de pharmacovigilance et d'information sur le médicament, service de pharmacologie.
Cissoko
H
H
Giraudeau
B
B
Jonville-Béra
A P
AP
Bensouda
L
L
Autret-Leca
E
E
D000328:Adult; D001569:Benzodiazepines / Q000009:adverse effects*; D016903:Drug Monitoring; D005260:Female; D018757:GABA Modulators / Q000009:adverse effects* / Q000627:therapeutic use; D006760:Hospitalization; D006801:Humans; D007040:Hypoventilation / Q000139:chemically induced; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000139:chemically induced*; D008431:Maternal-Fetal Exchange; D009123:Muscle Hypotonia / Q000139:chemically induced; D009357:Neonatal Abstinence Syndrome / Q000209:etiology; D010076:Oxazepam / Q000627:therapeutic use; D011247:Pregnancy; D011256:Pregnancy Outcome; D011263:Pregnancy Trimester, Third; D011963:Receptors, GABA-A / Q000187:drug effects*; D012119:Respiration / Q000187:drug effects; D012307:Risk Factors
D018757:GABA Modulators; D011963:Receptors, GABA-A; D001569:Benzodiazepines; D010076:Oxazepam