ADVERSE DRUG REACTIONS OF ANTI-EPILEPTIC DRUGS IN PEDIATRIC AGE GROUP IN A TERTIARY CARE TEACHING HOSPITAL; A CROSS-SECTIONAL STUDY

MOUSUMI DAS; VIJAY K SEHGAL; HARJINDER SINGH

doi:10.22159/ajpcr.2022.v15i3.43425

Authors

MOUSUMI DAS Department of Pharmacology, Government Medical College and Rajindra Hospital, Patiala, Punjab, India.
VIJAY K SEHGAL Department of Pharmacology, Government Medical College and Rajindra Hospital, Patiala, Punjab, India.
HARJINDER SINGH Department of Pediatric, Government Medical College and Rajindra Hospital, Patiala, Punjab, India.

DOI:

https://doi.org/10.22159/ajpcr.2022.v15i3.43425

Keywords:

Epilepsy, Antiepileptic drugs, Pediatric epilepsy side effect questionnaire, Adverse drug reactions

Abstract

Objectives: In this cross-sectional study, the aims were to analyze the incidence and pattern of adverse drug reactions (ADRs) of antiepileptic drugs in pediatric patient. Most common adverse effect and most common drug causing adverse effect were evaluated.

Methods: Study was conducted over 60 Patients for 6 months in out-patient basis pediatric department in Rajindra Hospital associated with GMC, Patiala, a tertiary care teaching hospital in Punjab. The patient diagnosed by the Pediatrician with epilepsy who fulfilling inclusion and exclusion criteria was enrolled after taking informed consent. ADRs were noted using Pediatric Epilepsy Side Effect Questionnaire at clinic visit and any other adverse effects reported by patients.

Results: In this study, a total of 60 children were enrolled. The mean age was 10.26±3.70, median were 11.00. 41 (68.33%) patients were boys and 19 (31.67%) were girls. In Cognitive ADRs with anti-epileptic drugs, there were total 17 ADRs reported. Valproate was causing most cognitive ADRs (32.43%). Among all cognitive ADRs, attention difficulty was the commonest complains. There were no motor and behavioral ADRs reported. Total 27 general neurological ADRs reported, which was highest reported ADRs. Among general neurological, Clobazam was causing highest ADRs (55.56%). 10 patients also reported tremor as another ADR and Clobazam causing most (22.22%).

Conclusion: In the present study, boys were developing more epilepsy than girls. Valproate was causing most ADRs. Among all cognitive ADRs, attention difficulty was the most common ADR. General neurological ADRs were highest reported ADRs.

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References

Hirtz D, Thurman DJ, Gwinn-Hardy K, Mohamed M, Chaudhuri AR, Zalutsky R. How common are the “common” neurologic disorders? Neurology 2007;68:326-37.

Smith DM, Metcalf SC, Wilcox SK. Pharmacotherapy of the epilepsies. In: Brunton L, Chabner B, Knollman B, editors. Goodman and Gilman’s the Pharmacological Basis of Therapeutics. 13th ed. United States: McGraw-Hills; 2018. p. 303-26.

Lowenstein DH. Seizures and epilepsy. In: Jameson LJ, Fauci SA, Kasper LD, Hauser LS, Longo LD, Loscalzo J, editors. Harrison’s Principles of Internal Medicine. 20th ed. United States: McGraw-Hill; 2018. p. 3050-67.

Van de Vrie-Hoekstra NW, De Vries TW, Van den Berg PB, Brouwer OF, de Jong-van den Berg LT. Antiepileptic drug utilization in children from 1997-2005 a study from the Netherlands. Eur J Clin Pharmacol 2008;64:1013-20.

Hara HS, Gupta A, Singh M, Raj R, Singh H, Pawar G, et al. Epilepsy in Punjab (India): A population based epidemiologic Study. Neuroepidemiology 2015;45:273-81.

Hsia Y, Neubert A, Sturkenboom MC, Murray ML, Verhamme KM, Sen F, et al. Comparison of antiepileptic drug prescribing in children in three European countries. Epilepsia 2010;51:789-96.

World Health Organization. Epilepsy Fact Sheet. Geneva: World Health Organization; 2019. Available from: https://web.archive.org/ web/20160311001129/http:/www.who.int/mediacentre/factsheets/ fs999/en

Perucca E, Meador KJ. Adverse effects of antiepileptic drugs. Acta Neurol Scand Suppl 2005;181:30-5.

Kaushik S, Chopra D, Sharma S, Aneja S. Adverse drug reactions of anti-epileptic drugs in children with epilepsy: A cross-sectional study. Curr Drug Saf 2019;14:217-24.

Daniel Raj T, Sylvia A, Chidambaranathan S, Nirmala P. A prospective study of drug utilization pattern of anti-epileptic drugs and their adverse effects in a tertiary care Hospital. Henry. Int J Curr Pharm Res 2016;9:42-5.

Anderson M, Egunsola O, Cherrill J, Millward C, Fakis A, Choonara I. A prospective study of adverse drug reactions to antiepileptic drugs in children. BMJ Open 2015;5:e008298.

Bansal D, Azad C, Kaur M, Rudroju N, Vepa P, Guglani V. Adverse effects of antiepileptic drugs in North Indian pediatric outpatients. Clin Neuropharmacol 2013;36:107-13.

Mistry RA, Solanki KC, Prajapati HK, Doshi TM, Trivedi HR. Drugutilizasion pattern of antiseizure drugs and their adverse effects in the pediatric population, in a tertiary care hospital attached to a medical college. Int J Basic Clin Pharmacol 2014;3:336-42.