Inadequate drug information for pregnant or lactating women: teratology information service follow-up

The assessment of the teratogenic risk of many drugs is very difficult or impossible because data are not available, and documentation is insufficient or based on minimal human information. The present study summarizes the outcome of newborns of women who took drugs during pregnancy and/or lactation without receiving adequate counselling. All calls received by the Beilinson Teratology Information Service during the last three years (1991–1993) were analyzed regarding the adequacy of the risk assessment process. These findings were compared to those for two control groups: women exposed to drugs with no known teratogenic effect, and women not exposed to drugs at all. We could not provide adequate counselling for 14 cases (in 1991), 17 (in 1992), and 14 (in 1993), or 6.6%, 4.8%, and 3%, respectively, of the total annual number of calls. The three groups studied proved to be similar in all maternal and neonatal characteristics, except for the number of abortions and prevalence of major congenital malformations which were higher in control group 1. The absence of data for a specific drug is disappointing and stressful for both the woman and her physician. The present small sample showed a good prognosis for the patients receiving inadequate counselling. These findings may provide some reassurance to the parents, but emphasize the need for caution and close monitoring of the fetus and newborn.