| アブストラクト | Dopamine agonists have been associated with an increased risk of developing impulse control disorders (ICDs). The US Food and Drug Administration (FDA) issued a safety warning in 2016 of a possible association between ICDs and aripiprazole. Recently, one large epidemiological study has confirmed this risk. In the present study, we aim to determine whether the safety signal of ICDs associated with aripiprazole detected by the FDA is replicated in the European pharmacovigilance database (EudraVigilance). We searched for all suspected spontaneous cases of ICDs associated with aripiprazole in EudraVigilance up to 23 February 2017. To assess the association between ICD cases and each dopamine agonist drug, we calculated the proportional reporting ratios (PRRs). Among 4 905 110 events of all types recorded in EudraVigilance, we found 160 cases of ICDs associated with aripiprazole. Aripiprazole fulfilled the criteria to generate a safety signal; PRR (95% confidence interval): 16.39 (13.97-19.24). Notably, the association seemed the strongest for the depot formulation of aripiprazole; PRR (95% confidence interval): 27.13 (17.22-42.75). Our analysis of the data contained in EudraVigilance confirms the safety signal detected last year by the FDA. Interestingly, for the first time, we show that the association seems the strongest for the intramuscular depot formulation of aripiprazole. |
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| ジャーナル名 | International clinical psychopharmacology |
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| 投稿日 | 2017/08/05 |
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| 投稿者 | Lertxundi, Unax; Hernandez, Rafael; Medrano, Juan; Domingo-Echaburu, Saioa; Garcia, Montserrat; Aguirre, Carmelo |
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| 組織名 | Pharmacy Service, Araba Mental Health Network.;Internal Medicine Service, Araba Mental Health Network, Vitoria-Gasteiz, Alava;Province.;Psychiatry Service, Bizkaia Mental Health Network, Portugalete.;Pharmacy Service, Alto Deba Integrated Health Care, Arrasate, Gipuzkoa Province.;Basque Pharmacovigilance Unit, Galdakao-Usansolo Hospital, Galdakao, Bizkaia;Department of Pharmacology, School of Medicine and Nursing, University of the;Basque Country, Leioa, Spain. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/28777129/ |
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