Students Research in Progress
Monday, October 14, 2024
01:00 PM–02:30 PM
Abstract
Introduction:
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is a severe hypersensitivity reaction linked to various medications, including antiepileptics. Symptoms include rash, fever, swollen lymph nodes, eosinophilia, and organ injury. The FDA recently issued warnings regarding DRESS risks with levetiracetam and clobazam.
Research Question or Hypothesis: What are the spontaneous post-marketing cases from the FDA Adverse Event Reporting System (FAERS) and literature case reports of DRESS associated with levetiracetam and clobazam?
Study Design: Retrospective review of FAERS database and systematic review of the literature for case reports.
Methods: Search of the FAERS database was conducted to identify DRESS cases related to levetiracetam and clobazam up to December 31, 2023. Additionally, literature was searched in PubMed, Embase, and the Cochrane Library up to February 29, 2024. Descriptive statistical analysis will provide a summary of demographics, clinical presentation, treatment, and outcomes.
Results: Preliminary data indicated 163 cases of DRESS associated with levetiracetam and 18 cases with clobazam from FAERS after applying exclusion criteria. Among FAERS cases, 44% were male, 40% female, and 16% unspecified, with a median age of 30-years. Hospitalization was required in 58% of cases, with 6% resulting in death. Literature review resulted 11 case reports for levetiracetam and two for clobazam, with a median age of 35-years. Further analysis is ongoing to examine time to event and common symptoms associated with reaction.
Conclusion: The findings from FAERS and literature review shows incidences of DRESS with levetiracetam and clobazam. While the result from this study will not establish a direct association between these agents and DRESS; it will serve as a valuable resource for raising awareness among providers since early recognition and intervention can reduce the severity of the reaction and improve patient outcomes. Further investigation is needed to determine any definitive mechanism and risk factors involved.
Presenting Author
Maryam Beirami B.S.University of South Florida Health Taneja College of Pharmacy
Authors
Jerica Singleton Pharm.D.
University of South Florida Health Taneja College of Pharmacy
Katlynd Sunjic Pharm.D.
University of South Florida
Bao Anh Tran PharmD, BCPS, BCCCP
University of South Florida Health Taneja College of Pharmacy