Causality, severity and preventability assessment of adverse cutaneous drug reaction: a prospective observational study in a tertiary care hospital.

Introduction: The number of subjects involved in a clinical trial are limited, whose findings cannot be extrapolated to the entire population.Due to the emergence of newer molecules the pattern of Adverse Cutaneous Drug Reaction(ACDR) also changes frequently. The need for this study is for early diagnosis, to reduce the morbidity and mortality due to ACDR and to ensure safety of the patients.

Material And Methods: Forty one subjects with the diagnosis of ACDR were included in the study for a period of 12 months(Jan 2009- Dec 2009). The informations such as patient demographic details, drug history, associated comorbid conditions and pattern of the skin reaction were noted. Assessment was done for causality, severity and preventability using separate valid scales.

Results: The most common ACDR was fixed drug eruption (43.9%) and the most common causative drug for the same was surprisingly found to be paracetamol. Antimicrobials were the most common causative drug group and two significant associated risk factors were multiple drug intake and history of allergy. Among the total reactions 78% were of probable category and 59% were of moderate level severity reaction. Out of which 12% of the cases were definitely preventable.