Summary
Objective:
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare and potentially fatal adverse skin reactions that are most commonly triggered by certain medications. One class of medications that have been highly associated with SJS/TEN reactions are antiepileptic drugs (AEDs). We sought to quantify the risk of SJS/TEN associated with AEDs as a class, as well as individual AEDs, in the United States.
Methods:
An analysis was performed of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from July 2014 through December 2017. Rates of SJS/TEN were calculated for each AED compared with all other non-AEDs. Reporting odds ratios (ROR), proportional reporting ratios (PRR), and 95% confidence intervals (CI) were calculated using OpenEpi.
Results:
AEDs had the most reports of SJS/TEN than any other medication class with 198 reports. AEDs as a class had a ROR of 8.7 (CI 7.5–10.2) and a PRR of 8.7 (CI 7.5–10.2) compared with all other non-AEDs. The AEDs with the highest risk estimates were zonisamide (ROR: 70.2, CI 33.1–148.7; PRR: 68.7, CI 32.9–143.5), rufinamide (ROR: 60.0, CI 8.3–433.5; PRR: 58.9, CI 8.4–411.5), clorazepate (ROR: 56.0, CI 7.8–404.1; PRR: 55.1, CI 7.8–385.0), lamotrigine (ROR: 53.0, CI 43.2–64.9; PRR: 52.2, CI 42.7–63.7), phenytoin (ROR: 26.3, CI 15.5–44.7; PRR: 26.1, CI 15.4–44.2), and carbamazepine (ROR: 24.5, CI 16.0–37.5; PRR: 24.3, CI 16.0–37.1).