A study on drug induced cutaneous adverse drug reactions at a tertiary care hospital, Mysore, India
Keywords:Cutaneous adverse drug reactions, Naranjos probability scale, Pharmacovigilance, Post-marketing surveillance
Background: Drugs, however safe and efficacious, are associated with risk of adverse reactions. Adverse Drug Reactions (ADRs) are one of the leading causes of morbidity and mortality. ADRs was rated as the fifth leading cause of death among all diseases. Consequences of ADRs range from diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of the study were to obtain information about drug induced cutaneous adverse reactions and to establish the causal relationship.
Methods: Observational cross sectional study, a total of 76 patients were recruited for the study,conducted in dermatology outpatient department of K R Hospital Mysore Medical College And Research Institute Mysore for 3 months. The drug reactions were recorded in ADR form of Central Drugs Standard Control Organisation (CDSCO). Causality was assessed using Naranjo algorithm and World Health Organization- Uppsala monitoring centre (WHO-UMC) criteria.
Results: 76 patients with CADRs were included in the study during the 3 months study period. Most common age group with CADRs was 20-30 years; with 55.73% of females 20.26% male and the most common suspected drug group causing CADRs was antimicrobial 35.46%. And most common lesion is maculopapular rashes. According to Naranjos scale 67.30% of CADRs were probably caused by drugs.
Conclusions: variety of drugs causes CADRs. Awareness among clinicians is required for active reporting of CADRs. Patients need to be educated for the cautious use of drugs causing ADRs to prevent the same.
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