Pharmacovigilance and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN): 55 Years of Retrospective Analysis of the FDA Adverse Event Reporting System (FAERS) Database.

Abstract

Purpose: This study investigates Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), severe and rare cutaneous adverse reactions often linked to drug use, utilizing data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database collected between 1969 and 2024. The objective is to identify the drugs most frequently associated with these conditions and to analyze trends in reporting over time. Methods: A retrospective analysis was conducted on 29 661 136 total adverse event reports, including 39 398 cases (0.13%) related to SJS/TEN. The drugs most commonly associated were classified using the Anatomical Therapeutic Chemical (ATC) system. The analysis included the severity, outcomes, gender, and age distribution of affected patients, focusing on drugs with the highest number of reports and their association with SJS/TEN. Regarding outcomes, their total number exceeds the number of SJS/TEN cases, as a single adverse drug reaction (ADR) can be associated with multiple outcomes. Results: Of the SJS/TEN cases, 97.79% were classified as severe, and 20.86% were fatal. Reports of SJS/TEN have increased significantly over the decades, peaking during the 2018 to 2020 period. The most frequently implicated drugs were Lamotrigine (9.17% of cases), Sulfamethoxazole/Trimethoprim (6.12%), and Allopurinol (5.88%). Other significant drugs included Phenytoin (5.05%), Acetaminophen (4.97%), and Ibuprofen (4.13%). Valdecoxib showed the highest percentage of SJS/TEN cases relative to its total adverse event reports (10.71%). Women were slightly more affected (51.03%) than men (39.30%). The most impacted age group was 18 to 64 years (45.12%), followed by 65 to 85 years (23.16%). Most reports were submitted by healthcare professionals (70.38%). Conclusion: The 55-year retrospective analysis highlights a rising trend in SJS/TEN reporting, attributed to increased awareness and vigilance in pharmacovigilance. These findings emphasize the importance of monitoring high-risk drugs, such as antiepileptics, analgesics, and antibacterials, and implementing strategies to mitigate associated risks. This study underscores the need for ongoing surveillance and education to enhance patient safety.