Use of Adverse Reaction Data Bases and Making Risk Assessments of Proposed Switch Candidates

Abstract

We are as never before at a point in our science that we are able to begin to evaluate the truth about drug risks. It is hoped that we will couple what we know about our evolving epidemiologic science with what we know about the medical arts. As this era of pharmaco-epidemiology continues to assess questions of drug safety in populations and apply public health principles to evaluate the switch of prescription drugs to OTC use, we will begin to see a more meaningful definition of terms like “Generally Recognized as Safe and Effective” and “acceptable risk.”