Intensive Monitoring of Adverse Drug Reactions to Antiepileptic Drugs in Neurology Department of a Secondary Care Hospital in U.A.E

Abstract

Objective: The general objective of this study was to identify and evaluate adverse drug reactions (ADRs) associated with antiepileptic drugs. Methodology: This was a cross-sectional study, conducted in the neurology department of a secondary care hospital. All the patients meeting the inclusion criteria were identified and evaluated. Data were collected from the electronic medical records and was entered into a data collection. All ADRs identified and reported were evaluated for causality, severity, preventability and predictability using different standard scales. Results: A total of 24 ADRs was detected, documented, evaluated and reported during the study period. The incidence was found to be 10%. Assessment of severity of the suspected ADRs revealed that 12% of suspected ADRs were mild level 1 (54.2%) and level 2 (41.7%). Causality assessment by WHO assessment scale reveals that majority of ADRs were considered as a probable 15 (62.5%). Higher incidence of ADRs was documented in females (58.8%). Central and peripheral nervous system was most commonly affected 09 (37.5%) organ system. Sodium valproate was the most common drug mostly associated with ADRs. All 24 (100%) of ADRs were definitely preventable. None of the demographic, disease or treatment-related factors were significant (p>0.05) predictors of ADRs. Conclusion: The findings of our study highlights the importance of regular monitoring and reporting of ADRs in the study setting. However, the study necessitates the importance of multicenter studies to further explore and evaluate the pattern of ADRs to different AEDs in the multiethnic population of U.A.E. Key words: Antiepileptic drugs, Adverse drug reactions, Pharmacovigilance, Sodium Valproate, Ovarian Cyst.