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Adverse drug reactions: a review of relevant factors.
J Clin Pharmacol. 2000 Oct; 40(10):1093-101.JC

Abstract

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drugs revealed that drugs with high potential for eliciting clinically significant ADRs are usually detected and either withdrawn from the market or placed on restricted use within the first year or two of marketing.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.

Authors+Show Affiliations

Office of Clinical Pharmacology & Biopharmaceutics, Food and Drug Administration, Rockville, Maryland 20857, USA.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

11028248

Citation

Ajayi, F O., et al. "Adverse Drug Reactions: a Review of Relevant Factors." Journal of Clinical Pharmacology, vol. 40, no. 10, 2000, pp. 1093-101.
Ajayi FO, Sun H, Perry J. Adverse drug reactions: a review of relevant factors. J Clin Pharmacol. 2000;40(10):1093-101.
Ajayi, F. O., Sun, H., & Perry, J. (2000). Adverse drug reactions: a review of relevant factors. Journal of Clinical Pharmacology, 40(10), 1093-101.
Ajayi FO, Sun H, Perry J. Adverse Drug Reactions: a Review of Relevant Factors. J Clin Pharmacol. 2000;40(10):1093-101. PubMed PMID: 11028248.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Adverse drug reactions: a review of relevant factors. AU - Ajayi,F O, AU - Sun,H, AU - Perry,J, PY - 2000/10/12/pubmed PY - 2001/2/28/medline PY - 2000/10/12/entrez SP - 1093 EP - 101 JF - Journal of clinical pharmacology JO - J Clin Pharmacol VL - 40 IS - 10 N2 - 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. SN - 0091-2700 UR - https://www.unboundmedicine.com/medline/citation/11028248/Adverse_drug_reactions:_a_review_of_relevant_factors_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0091-2700&date=2000&volume=40&issue=10&spage=1093 DB - PRIME DP - Unbound Medicine ER -