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PubMed · 15941187

Assessing potential risks and evaluating expected benefits.

Fadia T Shaya·Anna Gu
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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.

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Clinical Trials as TopicDrug ApprovalDrug PrescriptionsEvidence-Based MedicineHumansOutcome Assessment, Health CarePractice Patterns, Physicians'Risk AssessmentUnited StatesUnited States Food and Drug AdministrationJournal Article

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Fadia T Shaya, Anna Gu. 2005. Assessing potential risks and evaluating expected benefits.. https://pubmed.ncbi.nlm.nih.gov/15941187/

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