DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20213368

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

Sudha K. Mukhyaprana, Siddiraju Devipriya, Meenakshi Thirumalaiappan

Abstract


Background: More than 25 antiepileptic drugs (AEDs) are available in the Indian market to treat epilepsy of which many have similar efficacy but differ in their tolerability and are associated with many adverse drug reactions (ADRs). ADRs are one of the most common causes of death and clinical trials are not sufficient to uncover all the ADRs, hence post-marketing surveillance or pharmacovigilance is necessary. The aim of the study was to analyze the ADRs of AEDs by spontaneous reporting system under Pharmacovigilance Program of India (PvPI).

Methods: Suspected ADR reporting forms provided by PvPI were used to collect the data from healthcare professionals of Madras Medical College and Rajiv Gandhi Government General Hospital, Chennai.

Results: A total of 77 ADRs from 61 reports were analysed of which 34 were male and 27 were female patients and maximum were in the middle-aged adult group (N=44). Majority of the ADRs were related to skin and subcutaneous disorders (N=55) and most implicated ADR was found to be maculopapular rash (N=12) associated with phenytoin. Most of the ADRs were non-serious (N=42) and were probable category (N=45) as per WHO-UMC scale.

Conclusions: Monitoring ADRs in patients using antiepileptic drugs is a matter of importance; hence a robust pharmacovigilance practice is essential.


Keywords


Adverse drug reactions, Antiepileptic drugs, Pharmacovigilance, Pharmacovigilance program of India

Full Text:

PDF

References


Handa N, Singh R. Monitoring of Adverse Drug Reactions of Anti-Epileptic Agents in the Neurology Department. Int J Health Sci Res. 2018;8(8):136-40.

Gajjar BM, Shah AM, Patel PM. The pattern of adverse drug events to antiepileptic drugs: A cross-sectional study at a tertiary care teaching hospital. National J Physiol Pharm Pharmacol. 2016;6(6):616-21.

Nimesh S. A pharmacovigilance study of monitoring and focusing of adverse drug reactions induced by antiepileptic drugs used in epileptic patients. Pharm Pharmacol Int J. 2019;7(3):100-4.

Shanmugam S, Daniel L, Ahamed J. Meta-analysis of antiepileptic drugs induced Choreoathetosis in paediatric patients. Int J Med Rev Case Report. 2017;1(3):49-52.

Chol JH, Chan SP, Dong YK, Min GK, Sujeong K, Young MY, Sae HK, et al. Severe Cutaneous Adverse Reactions to Antiepileptic Drugs: A Nationwide Registry-Based Study in Korea. Allergy Asthma Immunol Res. 2019;11(5):69.

Zaccara G, Franciotta D, Perucca E. Idiosyncratic Adverse Reactions to Antiepileptic Drugs. Epilepsia. 2007;48(7):1223-44.

Ihtisham K, Ramanujam B, Srivastavaa S, Mehrab NK, Kaurc G, Khannad N, et al. Association of cutaneous adverse drug reactions due to antiepileptic drugs with HLA alleles in a North Indian population. Seizure: European J Epilepsy. 2019;66:99-103.

Alkhalil HJ, Sridhar SB, Rabbani SA, Omar AA. Intensive Monitoring of Adverse Drug Reactions to Antiepileptic Drugs in Neurology Department of a Secondary Care Hospital in U.A.E. J Young Pharmacist. 2019;11(2):192-6.

Jayalekshmi K, Palanisamy K, Ramanathan S, Akela S. A Study on the Adverse Drug Reactions Induced by Anti Epileptic Drugs in the Epileptic Patients. J Applied Pharmaceut Sci. 2016;6(5):119-23.

Khan SZ, Ali MA, Subhani G, Ushasree T. A study of serious adverse drug reactions with antiepileptic drugs: a pharmacovigilance study. Int J Basic Clin Pharmacol. 2018;7(5):922-5.

Singhal R, Ahmed K, Bhandri A, Santani DD. Newer Anti Epileptics: Adverse Drug Reactions Experience. J Pharm Res. 2012;5(2):1004-6.

Du Y, Lin J, Shen J, Ding S, Ye M, Wang L, et al. Adverse drug reactions associated with six commonly used antiepileptic drugs in southern China from 2003 to 2015. BMC Pharmacol Toxicol. 2019;20(1):7.

Sari SP, Salma NKS, Rianti A. Monitoring of anticonvulsant drug side effects in outpatients with epilepsy. Int J App Pharm. 2018;10(1):303-6.