Expecting the Unexpected — Drug Safety, Pharmacovigilance, and the Prepared Mind

Abstract

When a new drug is first marketed, findings regarding its efficacy and safety are commonly based on the experience of several thousand people who have been treated in controlled clinical trials. Despite extensive testing, rare adverse events (those that occur in less than one patient per thousand) can easily escape detection, and unforeseen interactions with coexisting clinical conditions or other drug therapies may remain unexplored. As a result, the characterization of the full safety profile of a new drug relies heavily on clinicians' careful observation of its effects in “real world” practice that is far removed from clinical-trial conditions. Discovery . . .