Adverse drug reactions: A review of relevant factors

We examined some of the factors that contribute to the development of adver se drug reactions (ADRs) and analyzed post-marketing ADR reports for 22 dru gs. The role of metabolic based drug-drug interaction in the development of ADRs can not be overstated. Assessment of the postmarketing ADR data for 2 2 drugs revealed that drugs with high potential for eliciting clinically si gnificant ADRs are usually detected and either with drawn from the market o r placed on restricted use within the first year or two of marketing. Postm arketing data could be a useful tool for understanding the ADR profile of d rugs if reporting can be adequately monitored and verified. It is hoped tha t 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.