Cutaneous adverse drug reactions: a 9-year study from a South Indian Hospital.

PURPOSE

To study the clinical spectrum of cutaneous adverse drug reactions (ADRs) in hospitalized patients retrospectively for 9 years and to establish a causal link between the drug and the reaction by using World Health Organization (WHO) causality definitions.

MATERIALS AND METHODS

A retrospective hospital-based study over a period of 9 years (January 1994 to December 2002) was carried out in the Department of Dermatology of St. John's Medical College Hospital to record various cutaneous ADRs of the hospitalized patients. Based on WHO causality definitions, ADRs were categorized into certain, probable, possible, and unlikely. The data was subjected to descriptive analysis.

RESULTS

Of the total 3541 patients, 404 (11.4%) were diagnosed as cutaneous ADRs, of which 52% were males and 48% females. A majority of the patients were in the age group of 21-40 years. Only drugs having certain and probable causal association to the reaction were considered for analysis (384). The most common type of ADR was maculopapular rash (42.7%), followed by Stevens-Johnson syndrome (SJS) (19.5%) and fixed drug eruption (11.4%). The drug class implicated was antibiotics (45%), followed by antiepileptics (19%), NSAIDs (19%). The reaction time (RT) recorded was in accordance with the previous reports.

CONCLUSION

A wide clinical spectrum of cutaneous ADRs ranging from mild maculopapular rash to serious toxic epidermal necrolysis (TEN) were observed. The incidence of life threatening cutaneous ADRs like SJS and TEN were found to be higher compared to studies published abroad. Antibiotics were the most commonly implicated drugs. A higher number of cutaneous ADRs were found to newer drugs like cephalosporins and fluroquinolones compared to previous studies.