Use and safety profile of antiepileptic drugs in Italy |
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Authors: | M L Iorio U Moretti S Colcera L Magro I Meneghelli D Motola A L Rivolta F Salvo G P Velo |
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Institution: | (1) Clinical Pharmacology Unit, Reference Centre for Education and Communication within the WHO Programme for International Drug Monitoring, University of Verona, Verona, Italy;(2) Department of Pharmacology, Interuniversity Research Centre of Pharmacoepidemiology, University of Bologna, Bologna, Italy;(3) Lombardy Centre of Pharmacovigilance, Milan, Italy;(4) Section of Pharmacology, Department of Clinical and Experimental Medicine and Pharmacology, University of Messina, Messina, Italy;(5) Clinical Pharmacology Unit, Policlinico G.B. Rossi, Piazzale L.A. Scuro 10, 37134 Verona, Italy |
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Abstract: | Objective To analyse and discuss the use and the safety profile of individual antiepileptic drugs (AEDs) in Italy.
Methods The AED safety data referred to the period January 1988–June 2005 and were obtained from the database of the Italian Interregional
Group of Pharmacovigilance (GIF). This database collects all spontaneous reports of suspected adverse drug reactions (ADRs)
from six Italian regions which are the main contributors to the Italian spontaneous reporting system. Individual AED consumption
data (defined daily dose/1,000 inhabitants per day) in the GIF area and in the whole of Italy referred to the period January
2003-June 2005 and were derived from drug sales data (Institute for Medical Statistics Health).
Results Phenobarbital was the most frequently used AED in the GIF area (4.26 DDD/1,000 inhabitants per day) followed by carbamazepine
(1.97), valproic acid (1.33) and gabapentin (1.10). AED consumption in the whole of Italy showed a similar pattern. Gabapentin
was the most frequently used AED among newer AEDs. In the GIF database 37,906 reports (up to June 2005) were present; 666
of them (1.76%) were associated with at least one AED (Anatomical Therapeutic Chemical code N03A). The AED with the highest
number of reports was carbamazepine (208 reports) followed by phenobarbital (98), gabapentin (80), phenytoin (56), valproic
acid (55), lamotrigine (51), oxcarbazepine (43) and vigabatrin (35). Use and toxicity profile were evaluated only for AEDs
associated with at least 30 reports. Skin reactions were the most frequently reported ADRs, followed by haematological, general
condition, hepatic, neurological and gastrointestinal adverse reactions. Phenobarbital, lamotrigine, carbamazepine and phenytoin
had the highest percentage of skin reactions (69, 67, 60 and 54%, respectively). Many haematological reactions were reported
for each AED; the highest percentage was related to valproic acid (25%). Vigabatrin was associated with the highest percentage
of reactions related to hearing, vision and other senses (97%). Phenytoin and valproic acid had the highest percentage of
hepatic reactions (30 and 20%), whereas gabapentin of nervous system, psychiatric, gastrointestinal and urinary reactions
(26, 21, 21 and 14%, respectively) and phenobarbital of musculoskeletal reactions (13%).
Conclusions In Italy antiepileptic drug therapy appears to be still dominated by traditional drugs. Our analysis showed a different safety
profile related to each AED. Some of the drug-adverse reaction associations discussed are not included in the Italian drug
leaflets or have not been reported before in the literature. |
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Keywords: | Antiepileptic drugs Adverse drug reactions Spontaneous reporting Drug utilization |
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