2014, Number 2
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Rev Cubana Neurol Neurocir 2014; 4 (2)
Adverse reactions to antiepileptic drugs reported in Bogota (Colombia, 2008–2012)
Chaves TNM, Quijano RJJ
Language: Spanish
References: 30
Page: 117-123
PDF size: 277.14 Kb.
ABSTRACT
Objective: To characterize adverse reactions to antiepileptic drugs occurred in Bogotá D.C. population reported to the District Pharmacovigilance Program between January 2008 and December 2012.
Methods: A descriptive pharmacovigilance study was carried out with reports of adverse events and problems associated with the use of antiepileptic drugs entered in the database of Bogotá D.C. District Pharmacovigilance Program.
Results: 173 reports of suspected adverse events and problems associated with the use of antiepileptic drugs in the population of Bogotá were evaluated. Of which 126 reports (72.8 %) were classified as suspected adverse drug reports and 20 reports (11.5 %) as problems related with drugs use. Antiepileptic drug with more number of notifications was carbamazepine with 41 notifications (23.7 %), followed by phenytoin with 40 notifications (23.1 %). The organ system most affected by adverse drug reactions was skin and it´s appendages (24.3 %). Regarding evaluation of reaction severity, most reports were for moderate adverse reaction suspected (43 %). With regard to causality most suspected adverse reactions were classified as possible (83 %).
Conclusions: The behavior of adverse reactions reported to antiepileptic drugs notified in District Pharmacovigilance Program of Bogotá, Colombia during 2008–2012 was similar with literature descriptions for each of the drugs included in antiepileptic’s group. The drug that reached the highest percentage of notifications as adverse reactions was carbamazepine.
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