It is estimated that 9 out of 10 women take a medication at some point during their pregnancy. However, prescription and over-the-counter drugs are not tested for safety in human pregnancy before they are approved for marketing. The current adverse event reporting schemes required after approval have proven to be inefficient means of identifying drug treatments that cause birth defects. As a consequence, the average time required to recognize the human teratogenic potential of a newly marketed drug is more than 7 years, and the teratogenic risk or safety associated with more than 90% of approved medications is unknown.
Health care providers require accessible and evidence-based information about the safety of medications in pregnancy, so they can make informed choices for their patients. Timely access to high quality information may reduce prolonged harmful medication exposures, decrease the number of preventable birth defects, and empower patients with accurate information about the true risks of medications they use, which in turn prevents unnecessary patient anxiety and possible pregnancy terminations.
Clinical assessment of human teratogenic risk requires careful interpretation of data obtained from several kinds of studies. Fortunately, the problem of collecting and analyzing the available data is greatly simplified by our clinical teratology knowledge database, TERIS – The Teratogen Information System.
TERIS serves to improve access of health care providers to available information and foster a systematic approach to risk assessment and risk management.