title: Assessing potential risks and evaluating expected benefits.
abstract: The recent withdrawal of rofecoxib from the market will have profound and long-term effects on the methods by which society views, assesses, and monitors risk. As is the case with many drugs, the rofecoxib experience was complex from both the scientific and regulatory standpoints. A drug is marketed in the United States only if its expected benefits outweigh its risks; a recent trend has also included several cost-effectiveness considerations in launch decisions, possibly spurring further debates on ethical implications. However, a great portion of the evidence about actual outcomes of therapies is revealed in the postmarketing phase of development. It is unclear how this understanding of treatment benefit and harm should actually relate to a specific clinical decision.
authors.affiliation: Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, School of Medicine, Epidemiology and Preventive Medicine, Baltimore 21201, USA. fshaya@rx.umaryland.edu
authors.forename: Fadia T
authors.initials: FT
authors.lastname: Shaya
authors.forename: Anna
authors.initials: A
authors.lastname: Gu
mesh_terms: D002986:Clinical Trials as Topic; D017277:Drug Approval; D011307:Drug Prescriptions; D019317:Evidence-Based Medicine; D006801:Humans; D017063:Outcome Assessment, Health Care; D010818:Practice Patterns, Physicians'; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration