Chapter 25 - Clinical Analysis of Adverse Drug Reactions

Abstract

This chapter presents the clinical analysis of adverse drug reactions (ADRs). ADRs represent an important public health problem. Despite efforts to reduce the incidences of medication-related adverse events, morbidity and mortality from drug-induced diseases continue to be unacceptably high. ADRs are occasionally classified as acute, subacute, or latent. Acute events are those observed within 60 minutes of the administration of a medication and include anaphylactic shock, severe bronchoconstriction, and nausea or vomiting. Subacute reactions occur within 1 to 24 hours and include maculopapular rash, serum sickness, allergic vasculitis, and antibiotic-associated diarrhea or colitis. Latent reactions require two or more days to become apparent and include eczematous eruptions, organ toxicity, and tardive dyskinesia. Some ADRs are caused by most or all medications in a class, while others are agent specific. Concurrent use of multiple medications is another major ADR risk factor. The potential for clinically significant drug interactions and additive adverse effects increases as the number of medications in a regimen increases. Age may be an important risk factor for the development of ADRs, and young children and the elderly may be particularly vulnerable. Detection of adverse reactions during clinical trials requires careful and systematic evaluation of study participants before, during, and after drug exposure.