title: Heart rhythm disturbances associated with rupatadine: a case series from the Spanish and Portuguese pharmacovigilance systems.
abstract: 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.
authors.affiliation: Instituto de Farmacoepidemiología, Universidad de Valladolid, Valladolid, Spain. carvajal@ife.uva.es
authors.forename: A
authors.initials: A
authors.lastname: Carvajal
authors.forename: D
authors.initials: D
authors.lastname: Macías
authors.forename: I
authors.initials: I
authors.lastname: Salado
authors.forename: M
authors.initials: M
authors.lastname: Sáinz
authors.forename: S
authors.initials: S
authors.lastname: Ortega
authors.forename: C
authors.initials: C
authors.lastname: Campo
authors.forename: J
authors.initials: J
authors.lastname: García del Pozo
authors.forename: L H
authors.initials: LH
authors.lastname: Martín Arias
authors.forename: A
authors.initials: A
authors.lastname: Velasco
authors.forename: S
authors.initials: S
authors.lastname: Gonçalves
authors.forename: R
authors.initials: R
authors.lastname: Pombal
authors.forename: R
authors.initials: R
authors.lastname: Carmona
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000139:chemically induced* / Q000453:epidemiology; D003533:Cyproheptadine / Q000009:adverse effects / Q000031:analogs & derivatives*; D016208:Databases, Factual; D005260:Female; D006634:Histamine H1 Antagonists / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011174:Portugal / Q000453:epidemiology; D013030:Spain / Q000453:epidemiology
chemical_list: D006634:Histamine H1 Antagonists; C103639:rupatadine; D003533:Cyproheptadine