Document Detail


Does proof of casualty ever exist in pharmacovigilance?
MedLine Citation:
PMID:  8240728     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Identifying the adverse effects of drugs, thus transforming adverse events into adverse drug reactions, is a useful and necessary but complicated task. Objective proof of a causal relationship between a drug and a specific event is quite exceptional. In most cases, this relationship remains subjective and is no more than inner conviction. Several means are at our disposal to achieve causal assessment: spontaneous reporting, clinical trials, cohorts with and without controls, and case-control studies, with each having advantages and limitations. The search for casualty in pharmacovigilance is a necessary scientific goal, but a high degree of suspicion may be all that is necessary to withdraw a drug from the market if it is suspected of causing serious adverse effects.
Authors:
M Auriche; E Loupi
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Drug safety     Volume:  9     ISSN:  0114-5916     ISO Abbreviation:  Drug Saf     Publication Date:  1993 Sep 
Date Detail:
Created Date:  1993-12-23     Completed Date:  1993-12-23     Revised Date:  2014-11-17    
Medline Journal Info:
Nlm Unique ID:  9002928     Medline TA:  Drug Saf     Country:  NEW ZEALAND    
Other Details:
Languages:  eng     Pagination:  230-5     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adverse Drug Reaction Reporting Systems
Causality*
Epidemiologic Methods
Humans
Product Surveillance, Postmarketing*
Research Design

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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