Pharmacovigilance of cutaneous drug reactions: A prospective observational study
DOI:
https://doi.org/10.7439/ijbar.v7i4.1643Abstract
Objective : To determine the frequency, severity and morphological pattern of ACDRs and their correlation with various risk factors. Methodology : A prospective, observational study was conducted in Muzaffarnagar Medical College and hospital, Muzaffarnagar Uttar Pradesh from Feb 2013 to Jan 2014 for one year. All patients of either sex and all age groups with suspected ACDRs attending/referred to Dermatology department were included. Results : Total of 90 cases were reported over a period of one year. ACDRs were observed with 0.5% incidence of patients attending OPD. ACDRs were commonly seen in adult age group (mean age 36.93 yrs) and have 3 or more drugs prescribed with equal gender distribution. As per Naranjo Algorithm, maximum number of ACDRs were of Possible type (74%), while 23 cases were of Probable category with female and male preponderance respectively. 71 of ACDRs were Moderate in severity (79%) followed by 11% of mild and 10% of severe category. Most common clinical pattern was Urticaria with 32 cases followed by 24 cases of Maculopapular Eruptions, 9 cases of Acneiform eruptions and 8 of fixed drug reactions and SJ Syndrome. Commonest Drug groups causing ACDRs were Antibiotics (38%) and Antiepileptics (30%).This was followed by NSAIDs induced ACDRs (9%). Phenytoin was the most common drug causing 12 ACDRs followed by 6 with Cabamazipine and Ceftrixone each and 5 cases with ATT. Conclusion : Incidence was low as compare to global incidence; better steps must be needed to strengthen the activity of pharmacovigilance in this state of the country.
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