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Título
Heart rhythm risturbances associated with rupatadine: a case series from the Spanish and Portuguese Pharmacovigilance Systems
Autor
Año del Documento
2009
Editorial
American Society for Clinical Pharmacology and Therapeutics
Descripción
Producción Científica
Documento Fuente
Clinical Pharmacology and Therapeutics. 2009 May;85(5):481-4
Resumo
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
Materias (normalizadas)
Insuficiencia cardiaca
Rupatadina
ISSN
0009-9236
Revisión por pares
SI
Patrocinador
Junta de Castilla y León. Consejería de Sanidad. Dirección General de Salud Pública e Investigación, Desarrollo e Innovación.
Idioma
eng
Derechos
openAccess
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