Citation

Gidai J, Acs N, Bánhidy F, Czeizel AE. Pharmacoepidemiol. Drug Saf. 2010; 19(2): 175-182.

Affiliation

Second Department of Obstetrics and Gynecology, School of Medicine, Semmelweis University, Budapest, Hungary.

Copyright

(Copyright © 2010, John Wiley and Sons)

DOI

10.1002/pds.1885

PMID

19998314

Abstract

OBJECTIVE: To evaluate the teratogenic effect of very large doses of nitrazepam in children born to pregnant women who attempted suicide and to check the feasibility of self-poisoning pregnant women model. DESIGN AND SETTING: Comparative analysis of exposed children and their unexposed sibs born to the same mothers who attempted suicide during the study pregnancy and admitted to the toxicological inpatients clinic, Budapest, 1960-1993. STUDY PARTICIPANTS: Of 1044 pregnant women who attempted suicide, 107 (10.3%) used large doses of nitrazepam alone or combination with other drugs, and 43 delivered live-born babies, these exposed children were evaluated. MAIN OUTCOMES MEASURES: Structural birth defects, i.e., congenital abnormalities (CAs), pregnancy age at delivery, and birth weight. RESULTS: The mean dose of nitrazepam used for suicide attempt was 204 mg. Of 43 exposed children, 13 (30.2%) were affected with CAs, while of their 29 sib controls, 3 (10.3%) (OR with 95%CI: 3.8, 1.0-14.6). Most CAs in exposed children were mild and belonged to the deformation type. The mean pregnancy age was shorter. CONCLUSIONS: The very large doses of nitrazepam used for suicide attempt during pregnancy resulted in a high rate of CAs which may be connected with the disruption of protein metabolism in fetal mesenchyma. The self-poisoning pregnant women model is feasible for the evaluation of teratogenic effect of drugs.

Language: en