| アブストラクト | Background/Objectives: Difficult-to-treat epileptic syndromes include conditions typically emerging in the first years of life and are characterized by a high rate of drug refractoriness. This study aimed to better define the safety profile of drugs used as adjunctive therapies for seizures associated with these syndromes using real-world pharmacovigilance data. Methods: We retrospectively analyzed the publicly available data regarding Individual Case Safety Reports (ICSRs), presenting stiripentol, cannabidiol, or fenfluramine as suspected drugs, reported on the Eudravigilance database until the third quarter of 2024. Data were evaluated with descriptive analyses and then with disproportionality measures, including the reporting odds ratio. Results: A total of 5986 ICSRs met the inclusion criteria (71.6% from cannabidiol, 14.5% fenfluramine, and 13.9% stiripentol). Significantly higher probabilities of reporting Cardiac disorders, Vascular disorders, and Respiratory, thoracic, and mediastinal disorders were observed with fenfluramine. Cannabidiol was associated with Product issues, whereas stiripentol was associated with injury, poisoning, procedural complications, Metabolism and nutrition disorders, and Blood and lymphatic system disorders. Conclusions: Our analysis did not highlight new and unexpected serious safety signals but confirmed the need to strictly monitor patients for the risk of adverse events. However, further prospective studies are required to better clarify the safety profile of these drugs in order to optimize their use. |
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| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
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| Pubmed追加日 | 2025/12/31 |
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| 投稿者 | Scala, Arianna; Trunfio, Teresa Angela; Pennisi, Chiara; Lombardo, Giovanni Enrico; Micale, Vincenzo; Martino, Serena Di; Fiorenza, Giorgia; Graziano, Adriana Carol Eleonora; Briglia, Marilena; Allia, Fabio; Giurdanella, Giovanni; Malaguarnera, Roberta; Battaglia, Rosalia; Gozzo, Cecilia; Palumbo, Fanny Erika; Vetro, Calogero; Improta, Giovanni; Toro, Mario Damiano; Drago, Filippo; Romano, Giovanni Luca; Gozzo, Lucia |
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| 組織名 | Department of Public Health, University of Naples Federico II, 80131 Naples,;Italy.;Department of Medicine and Surgery, University of Enna "Kore", 94100 Enna, Italy.;Department of Biomedical and Biotechnological Sciences, School of Medicine,;University of Catania, 95123 Catania, Italy.;Radiology Unit, Humanitas Istituto Clinico Catanese, 95045 Catania, Italy.;Division of Hematology, A.O.U. Policlinico "G.Rodolico-S. Marco", 95125 Catania,;Hematology and Bone Marrow Transplantation Unit, Hospital of Bolzano;(SABES-Azienda Sanitaria dell'Alto Adige), Teaching Hospital of Paracelsus;Medical University, 39100 Bolzano, Italy.;Department of Special Surgery Ophthalmology Department, University of Jordan,;Amman 11942, Jordan.;Clinical Trial Unit, University Hospital of Catania, 95125 Catania, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41471384/ |
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