Collection, Detection, Assessment, Monitoring and Prevention of Adverse Drug Reactions of Anti-Epileptic Drugs

Abstract

An adverse drug reaction (ADR) as defined by World Health Organization (WHO) is a noxious, unintended effect of a drug, occurring at normal doses in humans for prophylaxis, diagnosis or therapy of disease or for the modification of physiological function. ADRs rank among the top ten leading causes of mortality. The adverse effects (AEs) of antiepileptic drugs (AEDs) are highly prevalent and can be potentially life threatening. The objective of this study is to identify the ADR by chart review method, to determine the causality of the ADR by Naranjo's algorithm, to analyze the severity of the ADR by modified Hartwig method and to motivate the health care professionals to report ADRs in Neurology ward of Gauhatu Medical College and Hospital (GMCH), Guwahati, Assam, India. Preventability of ADR is done by Schumock and Thorton preventability scale. A prospective observational and hospital based case control study (Jan 2011-Dec 2011) was carried out in the Neurology ward of GHMC, including both outpatient and in-patient departments. All the values are statistically determined and expressed as Mean ± SD Graph Pad prism-5 statistical software was used for the data analysis. Statistical significance was defined as p < 0.05. All P values were two tailed. Out of the 2880 patients treated with AEDs for various indications, 85 (2.95 %) patients were reported with an incidence of 1 or more ADRs. The most common ADR involved the CNS (44 cases). Among them ataxia was found to be the most frequently reported (15 cases), followed by nystagmus (14 cases) and somnolence (9 cases). 37 cases involved the skin and connective tissue, the most common complaint being gum hypertrophy (23 cases). GI apparatus and liver involved 41 cases, the most frequent being nausea/vomiting (21 cases) and poor appetite (12 cases). Out of the 134 ADRs recorded, most of the ADRs were of Type A (n = 80, 59.70 %), followed by Type C (n = 37, 27.61 %), Type B (n = 16, 11.94 %) and Type D (n = 1, 0.75 %). Phenytoin resulted in a total of 38 (44.7 %) ADRs when prescribed as mono therapy followed by Sodium Valproate which caused a total of 19 (22.35 %) ADRs when prescribed alone. Anti-epileptic drugs have narrow therapeutic index, physician should be encouraged to do therapeutic drug monitoring in order to ensure effective treatment and prevent adverse drug reactions.

Pattern of adverse drug reactions occurring at department of neurology of a tertiary care hospital in India

“…This finding is supported by study conducted by Prudhivi et al, in which out of 130 ADR cases reported, type A cases were 66.15%. 8 On age distribution maximum ADRs were found in age group 71-80 years age group, as there is lower renal and hepatic microsomal drug metabolizing activity, elderly are more prone to develop cumulative toxicity while receiving prolonged medication. This distribution is in contrast to a study conducted by Thaha et al in which majority of patients were in age group 50-59 years.…”