Databases in the assessment of the effects of drugs during pregnancy.

Abstract

There is limited information on the effects of marketed drugs in pregnant women, largely because premarketing studies are not conducted in this population unless the agent is intended for specific use during pregnancy. Current information on the use of available medications during pregnancy includes 3 types of data: (1) case reports, (2) case-control studies, and (3) cohort studies. Assessments of pregnancy risk related to medication use most commonly involve case reports, and each year the Food and Drug Administration catalogs approximately 1000 suspected adverse drug experiences during pregnancy. The Food and Drug Administration, working with Michigan Medicaid, has developed a database of several hundred thousand pregnancy outcomes. Results of this study for asthma medications used between 1980 and 1992 are presented. However, interpretation of the results is complicated, and substantially more data are required, particularly as new medications become available.