CUTANEOUS ADVERSE DRUG REACTIONS: MECHANISTIC INSIGHTS AND PHARMACOVIGILANCE STRATEGIES

Abstract

This paper will discuss the molecular basis, clinical manifestations, and pharmacovigilance challenges associated with cutaneous adverse drug reactions (CADRs) with the aim of bridging mechanistic knowledge to efficacious safety-monitoring strategies.  The findings show that CADRs are caused by immune-mediated hypersensitivity, genetic susceptibility including the vulnerability related to the HLA, and metabolic alteration that influences the drug-protein interactions and T-cell activation.  Clinically, there were milder and more severe reactions including benign maculopapular eruptions, Stevens–Johnson syndrome, and toxic epidermal necrolysis.  The review of pharmacovigilance data bases indicated that under-reporting, lagging causality and inadequate clinical documentation were significant issues that complicated the discovery of signals.  The combination of electronic health records, patient-reported outcomes with AI-enhanced surveillance has a significant positive effect on the accuracy and timeliness of detecting adverse drug reactions.  In clinical practice, the study concludes that a pharmacovigilance and mechanistic approach is required to identify issues early, predict each patient risk, and make more appropriate treatment choices.  These findings support the development of safety measures to contain CADRs that are more adaptable, future-oriented and patient-centered.