Document Detail

Adverse drug reactions: a review of relevant factors.
MedLine Citation:
PMID:  11028248     Owner:  NLM     Status:  MEDLINE    
We examined some of the factors that contribute to the development of adverse drug reactions (ADRs) and analyzed postmarketing ADR reports for 22 drugs. The role of metabolic-based drug-drug interaction in the development of ADRs can not be overstated. Assessment of the postmarketing ADR data for 22 drugs revealed that drugs with high potential for eliciting clinically significant ADRs are usually detected and either withdrawn from the market or placed on restricted use within the first year or two of marketing. Postmarketing data could be a useful tool for understanding the ADR profile of drugs if reporting can be adequately monitored and verified. It is hoped that early evaluation of the clinically meaningful factors such as metabolism, pharmacogenetics, and effect of physiologic and pathophysiologic states on the clinical effect of a drug during drug development would significantly reduce the incidence and severity of post-marketing ADRs.
F O Ajayi; H Sun; J Perry
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  40     ISSN:  0091-2700     ISO Abbreviation:  J Clin Pharmacol     Publication Date:  2000 Oct 
Date Detail:
Created Date:  2001-01-16     Completed Date:  2001-02-01     Revised Date:  2005-11-16    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1093-101     Citation Subset:  IM    
Office of Clinical Pharmacology & Biopharmaceutics, Food and Drug Administration, Rockville, Maryland 20857, USA.
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MeSH Terms
Adverse Drug Reaction Reporting Systems*
Genetic Heterogeneity
Pharmaceutical Preparations / adverse effects*,  metabolism
Product Surveillance, Postmarketing*
Proteins / metabolism
Risk Factors
Reg. No./Substance:
0/Pharmaceutical Preparations; 0/Proteins

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