2024-03-29T12:26:41Zhttp://uvadoc.uva.es/oai/requestoai:uvadoc.uva.es:10324/90542021-06-23T09:49:05Zcom_10324_1133com_10324_931com_10324_894col_10324_1209
00925njm 22002777a 4500
dc
Carvajal García-Pando, Alfonso
author
Macías, Diego
author
Salado Valdivieso, María Inés
author
Sáinz Gil, María
author
Ortega, Sara
author
Campo, C.
author
García del Pozo, Javier
author
Martín Arias, Luis Hermenegildo
author
Velasco Martín, Alfonso
author
Gonçalves, R.
author
Pombal, R.
author
Carmona, R.
author
2009
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
Clinical Pharmacology and Therapeutics. 2009 May;85(5):481-4
0009-9236
http://uvadoc.uva.es/handle/10324/9054
10.1038/clpt.2008.269
481
5
484
Clinical Pharmacology and Therapeutics
85
Insuficiencia cardiaca
Rupatadina
Heart rhythm risturbances associated with rupatadine: a case series from the Spanish and Portuguese Pharmacovigilance Systems