Introduction and history of the Hungarian project for monitoring suicide attempts in pregnant women.
ABSTRACT The introduction describes the series of manuscripts resulting from the Hungarian Project for monitoring suicide attempts in pregnant women, as well as a history of the project, its various phases and participating individuals. This unique database contains information on all patients who attempted suicide by "self-poisoning" and were cared for at central toxicological inpatient clinic in Budapest, between 1960 and 1993. A total of 1044 patients were pregnant women, of which 19 died and 411 delivered live-born babies. Of these 411 live-born children, 367 exposed children were examined and/or evaluated. This is the first report of data on the human teratogenic potential of 93 medicinal products separately used for a suicide attempt during pregnancy. Each manuscript presents results for drugs used by at least 10 pregnant women for a suicide attempt, whereas the final paper summarizes the data of drugs used rarely for suicide attempt by pregnant women. Each patient consented to participate in the study. Critical information collected under medical supervision included examination of the patients upon admittance, stage of pregnancy at suicide attempt, blood levels of the drug(s) taken for the suicide attempt (at admittance), evaluation of the infant at birth for gestational age, weight and congenital abnormalities, and follow-up studies for 2 years after a child's birth. These studies provide insight into the potential effects of a high dose of a drug or drugs taken during pregnancy because it is well accepted that "pulse high doses" of a drug during the initial susceptible period of pregnancy are those most likely to result in congenital abnormality. Although it is obvious that these data are not sufficient to ensure safety, and that it is necessary to have a larger population of exposed children, to achieve better statistical power, as well as to include data on other populations, this collection of papers provides an important introduction of the so-called disaster epidemiological approach in human teratology. It shows the feasibility of such studies and suggests that an international surveillance system of self-poisoned pregnant women would be useful to better estimate risk and benefit of drug use during pregnancy. It is envisioned that the information provided will assist physicians and mothers in making better decisions regarding drug exposure during pregnancy.