Adverse Drug Reactions of Antiepileptic Drugs in Neurology Department of M.Y.H Indore, India: An Observational, Prospective Study

Saman Hussain; Anjali Kushwah; Archana Verma; Pooja Solanki Mishra; Kashish Sindhwani

doi:10.18502/jpc.v11i1.12635

Saman Hussain Department of Pharmacology, MGM Medical College, Indore, Madhya Pradesh, India.
Anjali Kushwah Department of Pharmacology, MGM Medical College, Indore, Madhya Pradesh, India.
Archana Verma Department of Neurology, MGM Medical College, Indore, Madhya Pradesh, India.
Pooja Solanki Mishra Department of Pharmacology, MGM Medical College, Indore, Madhya Pradesh, India.
Kashish Sindhwani Department of Pharmacology, MGM Medical College, Indore, Madhya Pradesh, India.

DOI: https://doi.org/10.18502/jpc.v11i1.12635

Keywords: Adverse Drug Reactions; Antiepileptic Drugs; Epilepsy; Pharmacovigilance

Abstract

Background: Epilepsy is the second most common neurological disorder that affects 1 percent of global population. Since antiepileptics have narrow therapeutic index having multiple adverse drug reactions (ADRs) thus have significant safety concerns. The aim of this study was to observe adverse drug reactions due to antiepileptics in neurology department M.Y.H. Indore, India.

Methods: An observational prospective study was done from November 2021 to January 2022. Patients having history of seizures attending neurology outpatient department at MYH Hospital, who were on antiepileptic drugs were recruited. Suspected adverse drug reaction forms were recorded and their causality assessment was done by Naranjo’s scale.

Results: Data of total 70 patients were recorded. Males reporting ADRs due to antiepileptics were 67.1% and females 32.8%. Using Naranjo’s scale, we noted 93.3% ADRs as “probable” and 6.7% as “possible”. Common causes of prescribing antiepileptic drugs were known case of epilepsy (78.5%),old case of neurocysticercosis (11.4%),post traumatic(4.3%),gliosis (2.8%) and tuberculoma (2.8%) .Most ADRs were dermatological 76% (rashes),central nervous system (16%) (nocturnal enuresis, poor school performance, dizziness, headache, sleep disturbances, personality changes) ,Gastrointestinal (8%) (gastric irritation, nausea, vomiting and hepatotoxicity) .Most common drug for causing ADRs were sodium valproate(58.5%),carbamazepine(17.14%),phenytoin(14.2%),leviteracetam(7.1%),and lamotrigine(2.8%).

Conclusion: Our study aimed us to know the incidence and patterns of adverse drug reactions due to antiepileptics in a tertiary care institute of central India. Despite of recent advances and novel therapies used for the treatment of epilepsy, conventional drugs like sodium valproate, phenytoin and carbamazepine still are the first choice for the management and treatment of seizures and their ADRs are very common.