Retrospective study of cutaneous adverse drug reactions reported at adverse drug reaction monitoring centre (AMC) at GMC/GGH, Guntur, Andhra - Pradesh, India
Journal Title: International Journal of Research in Pharmacology & Pharmacotherapeutics (IJRPP) - Year 2018, Vol 7, Issue 3
Abstract
Background One of the most common manifestation of adverse drug reactions is cutaneous adverse drug reaction, which includes skin and it's appendages, mucous membranes, occurring with a wide variation in morphological pattern. Aim To know the incidence, patterns and causality of Cutaneous Adverse Drug Reactions (CADRs), reported at ADR Monitoring Centre (AMC), Guntur Medical College/GGH. Materials & Methods After obtaining Institutional Ethics Committee approval, 840 CADRs reported to ADR Monitoring Centre (AMC), Guntur, over a period of 3 years were included in the study. For of each CADR - demographic details, suspected drug used, and concomitant medication details from their suspected Adverse Drug Reaction (sADR) reporting forms were taken. Causality assessment was done for each CADR with the help of WHO Causality assessment scale. Descriptive statistics were applied for the results analysis. Results Out of 840 CADRs, 567 (67.5%) occurred in females and 273 (32.5%) occurred in males. Age distribution ranged from 2 months to 75 years with a mean age of 37.09 + 12.74 SD years. 28 (3%) CADRs were serious and required hospitalization, 812(97%) CADRs were not serious and most of them were medically treated and recovered. 647 (77%) CADRs were due to antiretroviral drugs, 109 (13%) were due to anticancer drugs, 84 (10%) were due to antibacterial agents, NSAIDs, antiepileptics and other drugs. Maculopapular rash (58.6%) was the most common CADR observed in the study and other CADRs were pruritus (15%), mouth ulcerations (10.7%) etc. Conclusion Most of the CADRs were due to antiretroviral drug combinations and anticancer drug combinations. To prevent and reduce the incidence of CADRs, development and implementation of various strategies is necessary.
Authors and Affiliations
Dr. Vijaya Kumari Suryadevara. M. D
Pharmacovigilance - knowledge, attitude and practice among medical students in a teaching hospital of southern India
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