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.This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

Study of adverse drug reactions associated with antiepileptic drugs: a pharmacovigilance study using spontaneous reporting system

“…From out study, it was found that the predominance of ADRs was in males than the females and similar findings were shown in the previous study by Singh et al but it is contrary to study of Alkhalil et al 1,8 The prevalence of ADRs due to AEDs is more in the middle-aged adult group which is contrary to Jayalekshmi et al but similar to the study by Gajjar et al 2,9 In our study the most of the ADRs due to AEDs belonged to SOC of 'skin and subcutaneous disorder's which is in line with the study of Khan et al, but differs from the study conducted by Singhal et al 10,11 In the study it was found that the most of the ADRs are implicated by phenytoin which was similar to the study of Khan et al, but contrary to the study of Rohit Singhal et al and Du et al [10][11][12] From the study it was found that the most of the ADRs were serious which is contrary to the study of Singhal et al and Du et al 11,12 In this study the WHO-UMC causality assessment scale was used and found that the most of the ADRs were under 'probable' category which is contrast to Du et al, but similar to study of Sari et al in which Naranjo's causality assessment scale was used. 12,13…”