Risk Factors for Drug-Induced Severe Cutaneous Adverse Reactions: A Real-World Pharmacovigilance Analysis

Area of Science:

• Pharmacovigilance
• Clinical Pharmacology
• Drug Safety

Background:

• Severe cutaneous adverse reactions (SCARs) are rare but life-threatening hypersensitivity reactions to drugs.
• Limited understanding of drug risks necessitates research into SCAR-triggering medications.

Purpose of the Study:

• To identify risk factors and suspect drugs associated with SCARs.
• To analyze the FDA Adverse Event Reporting System (FAERS) database for drug-induced SCARs.

Main Methods:

• Case-control study design using FAERS data (2004-2025).
• Disproportionality analysis with reporting odds ratios (ROR).
• Logistic regression and LASSO analysis for risk factor identification; Bonferroni correction applied.

Main Results:

• Identified 103,337 drug-induced SCAR cases; median age 57.
• 415 drugs showed positive signals for SCARs.
• Independent risk factors included older age, male sex, and 114 drugs (e.g., amlodipine, bisoprolol, losartan).
• Distinct drug signals observed in Asian vs. non-Asian populations (e.g., allopurinol, lamotrigine in non-Asians; apalutamide, ipilimumab in Asians).
• Median time to onset (TTO) was 14 days, significantly shorter in Asians.

Conclusions:

• Older age, male sex, and specific drugs are independent risk factors for SCARs.
• FAERS data analysis highlights drugs requiring careful monitoring for SCARs.
• Early identification and discontinuation of suspected drugs are crucial for patient safety.