AIMS: This study used spontaneous reports of adverse events to estimate the risk for developing cardiac arrhythmias due to the systemic use of non-sedating antihistamine drugs and compared the risk estimate before and after the regulatory action to recall the over-the-counter status of some of these drugs. METHODS: All suspected adverse drug reactions (ADRs) reported until July 1999 to the Netherlands Pharmacovigilance Foundation Lareb were used to calculate the ADR reporting odds ratio, defined as the ratio of exposure odds among reported arrhythmia cases, to the exposure odds of other ADRs (non-cases), adjusted for gender, age, reporter, year of reporting and comedication, stratified for the periods before and after the governmental decision in the Netherlands. RESULTS: Seven-hundred and thirty-seven cases of arrhythmia were reported, out of which there were 43 instances where the patients were using non-sedating antihistamines. In general non-sedating antihistamines are associated with cardiac arrhythmia to a higher extent in comparison with other drugs (ADR reporting odds ratio 2.05 [95% CI: 1.45, 2.89]). The association between arrhythmias and non-sedating antihistamine drugs calculated before 1998 was not significantly higher than 1 (OR 1.37 [95% CI: 0.85, 2.23]), whereas the risk estimate calculated after the governmental decision did significantly differ from 1 (OR 4.19 [95% CI: 2.49, 7.05]). CONCLUSIONS: Our data suggest that non-sedating antihistamines might have an increased risk for inducing arrhythmias. Our findings, however, strongly suggest that the increased risk identified can at least partly be explained by reporting bias as a result of publications about and mass media attention for antihistamine induced arrhythmias.
AIMS: This study used spontaneous reports of adverse events to estimate the risk for developing cardiac arrhythmias due to the systemic use of non-sedating antihistamine drugs and compared the risk estimate before and after the regulatory action to recall the over-the-counter status of some of these drugs. METHODS: All suspected adverse drug reactions (ADRs) reported until July 1999 to the Netherlands Pharmacovigilance Foundation Lareb were used to calculate the ADR reporting odds ratio, defined as the ratio of exposure odds among reported arrhythmia cases, to the exposure odds of other ADRs (non-cases), adjusted for gender, age, reporter, year of reporting and comedication, stratified for the periods before and after the governmental decision in the Netherlands. RESULTS: Seven-hundred and thirty-seven cases of arrhythmia were reported, out of which there were 43 instances where the patients were using non-sedating antihistamines. In general non-sedating antihistamines are associated with cardiac arrhythmia to a higher extent in comparison with other drugs (ADR reporting odds ratio 2.05 [95% CI: 1.45, 2.89]). The association between arrhythmias and non-sedating antihistamine drugs calculated before 1998 was not significantly higher than 1 (OR 1.37 [95% CI: 0.85, 2.23]), whereas the risk estimate calculated after the governmental decision did significantly differ from 1 (OR 4.19 [95% CI: 2.49, 7.05]). CONCLUSIONS: Our data suggest that non-sedating antihistamines might have an increased risk for inducing arrhythmias. Our findings, however, strongly suggest that the increased risk identified can at least partly be explained by reporting bias as a result of publications about and mass media attention for antihistamine induced arrhythmias.
Authors: Peter G M Mol; Sabine M J M Straus; Sigrid Piening; Jonie T N de Vries; Pieter A de Graeff; Flora M Haaijer-Ruskamp Journal: Drug Saf Date: 2010-06-01 Impact factor: 5.606
Authors: June Almenoff; Joseph M Tonning; A Lawrence Gould; Ana Szarfman; Manfred Hauben; Rita Ouellet-Hellstrom; Robert Ball; Ken Hornbuckle; Louisa Walsh; Chuen Yee; Susan T Sacks; Nancy Yuen; Vaishali Patadia; Michael Blum; Mike Johnston; Charles Gerrits; Harry Seifert; Karol Lacroix Journal: Drug Saf Date: 2005 Impact factor: 5.606
Authors: Manfred Hauben; Lester Reich; Eugène P Van Puijenbroek; Charles M Gerrits; Vaishali K Patadia Journal: Eur J Clin Pharmacol Date: 2006-08-03 Impact factor: 2.953
Authors: Paul Avillach; Preciosa M Coloma; Rosa Gini; Martijn Schuemie; Fleur Mougin; Jean-Charles Dufour; Giampiero Mazzaglia; Carlo Giaquinto; Carla Fornari; Ron Herings; Mariam Molokhia; Lars Pedersen; Annie Fourrier-Réglat; Marius Fieschi; Miriam Sturkenboom; Johan van der Lei; Antoine Pariente; Gianluca Trifirò Journal: J Am Med Inform Assoc Date: 2012-09-06 Impact factor: 4.497
Authors: Pedro Lopes; Tiago Nunes; David Campos; Laura Ines Furlong; Anna Bauer-Mehren; Ferran Sanz; Maria Carmen Carrascosa; Jordi Mestres; Jan Kors; Bharat Singh; Erik van Mulligen; Johan Van der Lei; Gayo Diallo; Paul Avillach; Ernst Ahlberg; Scott Boyer; Carlos Diaz; José Luís Oliveira Journal: PLoS One Date: 2013-12-11 Impact factor: 3.240