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 23-nov-2024