| アブストラクト | OBJECTIVE: This study aimed to describe reports of psychiatric adverse drug reaction (ADR) in the spectrum of bipolar (manic features) or psychotic disorders that occurred under tumor necrosis factor alpha (TNF-alpha) inhibitors therapy. METHODS: We searched the French pharmocovigilance database for reports of psychiatric ADR in the spectrum of bipolar (manic features) or psychotic disorders during treatment with TNF-alpha inhibitors. Psychiatric symptoms were divided in 2 categories: (i) confirmed diagnosis of manic episode or acute psychosis and (ii) psychiatric symptoms with psychotic or manic features but not meeting sufficient criteria for diagnosis of psychosis or manic disorder. RESULTS: Overall, 9942 reports of ADR were registered in the French pharmacovigilance database with TNF-alpha inhibitors, including 243 reports of psychiatric ADR. Among them, we identified 41 reports of psychotic or manic disorders as define above: 9 characterised manic episodes and 32 psychiatric disorders with psychotic or manic features. TNF-alpha inhibitors were the only medication suspected in 23 reports (56%). The delay between starting TNF-alpha inhibitors treatment and onset of symptoms varied from hours to years with a median time of 40 days. Psychiatric symptoms improved in 22/23 patients in whom the TNF-alpha inhibitor was withdrawn. CONCLUSION: Depressive disorders are well-known ADR of TNF-alpha inhibitors, but we report, here, 41 reports of psychiatric ADR diagnosed as manic or psychotic disorders or in the spectrum of bipolar or psychotic disorders with these treatments. Epidemiological studies are needed to confirm this signal. |
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| 投稿者 | Yelnik, Cecile Marie; Gaboriau, Louise; Petitpain, Nadine; Theophile, Helene; Delaporte, Emmanuel; Carton, Louise; Gautier, Sophie; Lambert, Marc |
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| 組織名 | Inserm U1167; CHU Lille, service de medecine interne et de medecine;polyvalente-post urgences, 59000 Lille, France; Universite de Lille, 59000 Lille,;France. Electronic address: cecile.yelnik@orange.fr.;CHU Lille, centre regional de pharmacovigilance, 59000 Lille, France.;CHU Nancy, centre regional de pharmacovigilance, 54000 Nancy, France.;CHU Bordeaux, centre regional de pharmacovigilance, 33000 Bordeaux, France.;Universite de Lille, 59000 Lille, France; Service de dermatologie, CHU de Lille,;59000 Lille, France.;CHU Lille, centre regional de pharmacovigilance, 59000 Lille, France; Service de;psychiatrie et d'addictologie, CHU de Lille, 59000 Lille, France.;Universite de Lille, 59000 Lille, France; CHU Lille, centre regional de;pharmacovigilance, 59000 Lille, France.;France. |
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