RT info:eu-repo/semantics/article T1 Heart rhythm risturbances associated with rupatadine: a case series from the Spanish and Portuguese Pharmacovigilance Systems A1 Carvajal García-Pando, Alfonso A1 Macías, Diego A1 Salado Valdivieso, María Inés A1 Sáinz Gil, María A1 Ortega, Sara A1 Campo, C. A1 García del Pozo, Javier A1 Martín Arias, Luis Hermenegildo A1 Velasco Martín, Alfonso A1 Gonçalves, R. A1 Pombal, R. A1 Carmona, R. K1 Insuficiencia cardiaca K1 Rupatadina AB We searched the Spanish and Portuguese pharmacovigilance databases for spontaneous case reports of heart rhythm disturbances associated with rupatadine and other new H1 antihistamines. Five cases were found involving patients treated with rupatadine (13.9% of all reports relating to this drug). In all five cases, the reaction started after exposure and resolved when the drug was discontinued. In two cases, rupatadine was the only medication being taken by the patient, and no other condition that could explain the heart rhythm disturbances was diagnosed. The reporting odds ratio was 3.2 (95% confidence interval, 1.0-10.5). The reporting rate was 2 cases per 100,000 patients treated per year (95% confidence interval, 0.4-6.0). These results suggest a causal relationship between rupatadine and heart rhythm disturbances PB American Society for Clinical Pharmacology and Therapeutics SN 0009-9236 YR 2009 FD 2009 LK http://uvadoc.uva.es/handle/10324/9054 UL http://uvadoc.uva.es/handle/10324/9054 LA eng NO Clinical Pharmacology and Therapeutics. 2009 May;85(5):481-4 NO Producción Científica DS UVaDOC RD 28-mar-2024