Pharmacovigilance of Severe Cutaneous Adverse Drug Reactions

Abstract

Background: Severe cutaneous adverse drug reactions (SCARs) are idiosyncratic reactions comprising 2% of all drug-induced skin reactions. These include Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. These dermatologic emergencies lead to increased morbidity, mortality, and economic burden and may be a cause of litigation. Objectives: The aim was to study the clinicoepidemiological profile of SCARs and establish causal association. Materials and Methods: Patients presenting with SCARs over a period of 2 years were included in this observational, cohort, hospital-based study conducted in a tertiary care center in western India. The patterns of drug reactions were analyzed, and the drug causality was established. Results: A total of 62 patients were included in this study. SJS was the most common pattern of drug reaction observed. Aromatic anticonvulsants (phenytoin and carbamazepine), antimicrobials (co-trimoxazole and amoxicillin), and nonsteroidal anti-inflammatory drugs were the most common drugs implicated. Drug reactions in people living with HIV/AIDS on antiretroviral therapy were noteworthy. Conclusion: SCARs represent the most challenging dermatoses in terms of survival, sequelae, and quality of life. Prompt withdrawal of the offending drug and strict pharmacovigilance can improve the prognosis of SCARs. There is a need for exploration of newer genetic associations which may be the only tool to predict these severe reactions.

Keywords

• adverse drug reactions
• pharmacovigilance
• stevens–johnson syndrome
• toxic epidermal necrolysis