Abstract

Background:
The National Coordination Centre for the Pharmacovigilance Programme of India regularly issues drug safety alerts (DSA) to sensitize health care professionals. Cutaneous adverse reactions are commonly reported; hence, relevant knowledge about skin disorders comprising drug safety alerts, which are India-centric, further emphasizes the importance of pharmacovigilance.

Aim:
This study aimed to evaluate the clinical pattern and the drugs implicated in DSAs belonging to the system organ class (SOC) of skin and subcutaneous tissue disorders.

Methods:
The “System Organ Class” classification by Medical Dictionary for Regulatory Activities was used to identify DSAs from the skin and subcutaneous tissue category. These safety alerts were evaluated for the type of disorder and the drugs implicated.

Results:
Of the 181 DSAs, 83 (45.86%) belonged to the SOC of skin and subcutaneous tissue disorders. The most common cutaneous disorder is acute generalized exanthematous pustulosis (AGEP), followed by fixed drug eruption (FDE) and drug reaction with eosinophilia and systemic symptoms (DRESS). Antimicrobials accounted for 44.58% of cutaneous DSAs, followed by cardiovascular drugs in 14.46%.

Conclusion:
The most common cutaneous adverse reactions comprising DSAs are AGEP, followed by FDE and DRESS. Antimicrobials are the most common drug class implicated in safety alerts, followed by cardiovascular drugs.

Key words: Adverse drug reaction; Drug safety alert; Pharmacovigilance.