Abstract:
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.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
S RB,Narayan SS,Sharma GR,Rodrigues RJ,Kulkarni Cdoi
10.1002/pds.1540subject
Has Abstractpub_date
2008-08-01 00:00:00pages
807-12issue
8eissn
1053-8569issn
1099-1557journal_volume
17pub_type
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journal_title:Pharmacoepidemiology and drug safety
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