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Cutaneous adverse drug reactions from a teaching hospital in Bengaluru: An observational study to determine the spectrum and outcome

Jayanthi C R, Ankita Bedwal, Kavitha Rajarathna.


Background: Cutaneous adverse drug reactions (CADRs) are frequent manifestations of drug reactions that can lead to discontinuation of treatment, impaired quality of life and increased economic burden. Knowledge of drugs causing CADRs help in choosing safer drugs.

Aims and Objectives: To determine the clinical spectrum, causality, severity, and preventability of CADRs.

Materials and Methods: An observational study conducted from 2012 to 2016 to analyze the CADRs reported from Dermatology Department, of Bangalore Medical College and Research Institute to adverse drug reaction (ADR) Monitoring Center. Patient’s demographics, clinical and drug data, details of ADRs were collected as per CDSCO form. Causality, severity, and preventability were assessed using relevant scales.

Results: Out of 809 ADRs reported, 230 were CADRs. Male preponderance (56%) was seen. Age group of 21-40 years (57%) was most affected. Maximum CADRs were seen with beta-lactam class of drugs (20%), followed by nonsteroidal anti-inflammatory drugs (17.4%) and antiepileptics (13.5%). Maculopapular rash (26%) was the most common CADR. Stevens–Johnson syndrome (SJS) contributed to the majority of severe CADRs. Causative drug was withdrawn in 90% of cases. Causality assessment indicated 80.4% as probable and 19.6% as possible cases. 81% of CADRs were of moderate severity, and only 6% were severe like SJS. 11% were “definitely preventable” CADRs.

Conclusion: Wide clinical spectrum of CADRs was observed. Definitely preventable CADRs were due to improper recording of history of drug allergy and wrong choice of self-medication by the patients. Inconsistent with the previous literature, the incidence of diclofenac-induced SJS was found high.

Key words: Cutaneous Adverse Drug Reactions; Causality; Severity; Preventability

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