Labeling: What Should it Say,and How Should it Say it?

Abstract

“Labeling,” limited in this article to the approved prescribing information or data sheet, presents certain information about a drug on which physicians make their prescribing decisions. Questions are posed as to what is desired in labeling by physicians, regulators, lawyers, and marketers. The author's views are presented concerning what labeling is not and what it should not attempt to say. Problems in “how it is said” include: (1) the excessive use of modifying adjectives and adverbs, (2) the presentation of incidence of ADEs and the degree of risk, (3) ambiguous warnings, (4) definitions of contraindication, (5) the ADE “laundry list”, (6) “symptoms and signs” versus “diagnostic terms”, (7) clinical relevance of interactions, (8) “long-term” versus “short-term” use, and (9) “overdose”. Suggestions are made toward improving the presentation of safety (risk) information in labeling.