The estimation of human teratogenic/fetotoxic risk of exposures to drugs on the basis of Hungarian experience: a critical evaluation of clinical and epidemiological models of human teratology.

BACKGROUND: The risk and benefit of drug use during pregnancy needs a better balance because the teratogenic risk is exaggerated.

OBJECTIVE: To show the objectives and results of the Hungarian Congenital Abnormality Registry, the Hungarian Case-Control Surveillance of Congenital Abnormalities and the Budapest Monitoring System of Self-poisoned Pregnant Women in the estimation of human teratogenic/fetotoxic risk of exposures to drugs that resulted in the statement mentioned in the Background.

METHODS: The description of the methodology in the Hungarian Congenital Abnormality Registry, Hungarian Case-Control Surveillance of Congenital Abnormalities and the Budapest Monitoring System of Self-poisoned Pregnant Women shows strengths and limitations of these systems and may help to understand better the role of these public health oriented post-marketing systems of drug teratogenicity.

RESULTS/CONCLUSIONS: The above Hungarian public health systems want to minimise the methodological weaknesses (e.g., recall bias) compared to other models and previous studies, but the teratogenic risk estimation of exposures to drugs can result in only signals, which need confirmation in other studies. These systems are important but only some parts of the whole range in the evaluation of drug teratogenicity. The experiences of the author led to his conclusion that the exaggeration of teratogenic risk may cause hazards for both pregnant women and their fetuses.