Teratological experience from the drug surveillance of a pharmaceutical company

The aim of this paper is to illustrate how adverse event reports can contribute to drug safety in the field of reproductive toxicity. This is a question of great public concern which is, however, normally not addressed in clinical trials unless pregnancy and lactation are the states intended for study. Most trials exclude pregnant or lactating women from entering. Since 1980, Hoechst AG had kept all spontaneous reports with respect to adverse events on computer file. To date about 20,000 reports have been entered. All cases which were in any way related to reproductive toxicity were compiled. There were three main categories of reports: abortion/stillbirth, functional abnormalities, anatomical abnormalities (teratologic events in a narrower sense). The results showed: an overall low incidence of reports, no specific teratologic pattern (however a pattern was seen with functional abnormalities). (Tab. 3, Ref. 5.)