Document Detail

Pattern of adverse drug reactions to anti-epileptic drugs: a cross-sectional one-year survey at a tertiary care hospital.
MedLine Citation:
PMID:  18213610     Owner:  NLM     Status:  MEDLINE    
PURPOSE: To investigate pattern and extent of adverse drug reactions (ADRs) associated with AEDs and to identify safer options for treatment of epilepsy. METHOD: Study was a retrospective, cross-sectional survey. Data from patients with epilepsy at the out-patient and in-patient of Neurology Department was collected in a specially designed proforma. Causality and severity of ADRs was categorized as per WHO guidelines. RESULTS: Among 788 patients with epilepsy, 80 (10.27%) had ADRs. ADRs with AED monotherapy were 9.18% and with polytherapy were 11.56%. ADRs with conventional and newer AED monotherapy was 10.24% and 6.84%, respectively, and were maximum with phenytoin and clobazam (14.28% and 12.5%). ADRs were mild in 4.16%, moderate in 70.83% and severe in 25% patients. Causality was probable in 65.62%, possible in 13.54% and definite in 20.83%. Patients (15/80) were hospitalized due to ADRs. Age and gender distribution showed statistically significant difference in occurrence of ADRs (p < 0.05). Chi-square test for poly versus monotherapy and conventional versus newer AEDs did not show any significant difference. CONCLUSIONS: Study showed maximum ADRs with AED polytherapy with no significant difference in frequency and severity of ADRs between conventional versus newer AEDs. This finding needs further investigation in larger number of patients to identify safer treatment options for epilepsy.
Roopa B S; Sujatha S Narayan; G R K Sharma; Rashmi J Rodrigues; Chanda Kulkarni
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Pharmacoepidemiology and drug safety     Volume:  17     ISSN:  1099-1557     ISO Abbreviation:  Pharmacoepidemiol Drug Saf     Publication Date:  2008 Aug 
Date Detail:
Created Date:  2008-07-30     Completed Date:  2008-10-27     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9208369     Medline TA:  Pharmacoepidemiol Drug Saf     Country:  England    
Other Details:
Languages:  eng     Pagination:  807-12     Citation Subset:  IM    
Department of Pharmacology, St John's Medical College and Hospital, Bangalore, India.
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MeSH Terms
Aged, 80 and over
Anticonvulsants / adverse effects*
Child, Preschool
Cross-Sectional Studies
Data Collection
Epilepsy / drug therapy*
Middle Aged
Retrospective Studies
Reg. No./Substance:

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