Congenital abnormalities of 88 children born to mothers who attempted suicide with phenobarbital during pregnany: the use of a disaster epidemiological model for the evaluation of drug teratogenicity.

OBJECTIVE

To study the effect of large doses of phenobarbital used for a suicide attempt during pregnancy for fetuses to estimate the teratogenic potential of phenobarbital.

DESIGN AND

SETTING

Comparative analysis of exposed children and their unexposed sibs born to pregnant patients who attempted suicide during pregnancy and admitted to the toxicological inpatient clinic, Budapest, 1960-1993.

STUDY

PARTICIPANTS

Of 1044 self-poisoned pregnant women, 88 used phenobarbital for suicide attempt and delivered newborn babies.

MAIN OUTCOME MEASURES: Structural birth detects, i.e., congenital abnormalities (CAs).

RESULTS

Doses ranged between 400 and 3000 mg of phenobarbital in 88 pregnant women who attempted suicide with this drug during pregnancy and later delivered live-born babies. Twelve (13.6%) of 88 exposed children and eight (10.3%) of 78 sibs were affected with CAs (odds ratios (OR) with 95%CI: 1.4, 0.6-3.5). Of 88 exposed children, 34 were born to mothers who attempted suicide with phenobarbital between the 3rd and 12th postconceptional weeks, the critical period of most CAs; 3 had CAs (diaphragmatic defect, multiple CA, undescended testis), but only diaphragmatic defect might be associated with phenobarbital used for suicide attempt.

CONCLUSIONS

The use of phenobarbital once but extremely large doses in non-epileptic pregnant women does not seem to pose a significant risk for CAs. Our experiences show the feasibility and benefits of the disaster epidemiological self-poisoning model for estimating human teratogenic risks of drug exposure.