Use of a spontaneous adverse drug events database for identification of unanticipated drug benefits.
We describe an examination of a spontaneous adverse events database in an effort to identify agents with possible hitherto unknown antiangiogenic properties. The surrogate end point was abnormal wound healing. This analysis represents use of this database for identification of a possibly useful in vivo side effect. Through thoughtful choice of end points, we believe spontaneous adverse events databases have the capacity for hypothesis generation in a search for unanticipated beneficial drug properties.
Brinker
Allen
A
Food and Drug Administration, Center for Drug Evaluation and Research, Office of Postmarketing Drug Risk Assessment, Rockville, MD 20857, USA.
Beitz
Julie
J
D016907:Adverse Drug Reaction Reporting Systems; D020533:Angiogenesis Inhibitors / Q000494:pharmacology*; D016208:Databases, Factual; D006801:Humans; D017891:Pharmacoepidemiology / Q000379:methods; D014481:United States; D014945:Wound Healing / Q000187:drug effects*
D020533:Angiogenesis Inhibitors