A comparison of three different sources of data in assessing the frequencies of adverse reactions to amiodarone

Abstract

The distributions of ADR rank order and relative frequencies are dissimilar among the three datasets, as each dataset compiles information in a different way. Nevertheless, each dataset has its own specific strengths, and all three should be used together in obtaining a complete picture of a drug's safety profile. Important therapeutic and regulatory decisions should not simply be based on one source of data.