Pro-arrhythmic potential of oral antihistamines (H1): combining adverse event reports with drug utilization data across Europe

PloS One
Elisabetta PoluzziFabrizio De Ponti

Abstract

There is appreciable utilisation of antihistamines (H1) in European countries, either prescribed by physician and purchased by patients for self-medication. Terfenadine and astemizole underwent regulatory restrictions in '90 because of their cardiac toxicity, but only scarce clinical data are available on other antihistamines. To investigate the pro-arrhythmic potential of antihistamines by combining safety reports of the FDA Adverse Event Reporting System (FAERS) with drug utilization data from 13 European Countries. We identified signals of antihistamine arrhythmogenic potential by analyzing FAERS database for all cases of Torsades de Pointes (TdP), QT abnormalities (QTabn), ventricular arrhythmia (VA) and sudden cardiac death/cardiac arrest (SCD/CA). Number of cases ≥3 and disproportionality were used to define alert signals: TdP and QTabn identified stronger signals, whereas SCD/CA identified weaker signals. Drug utilization data from 2005 to 2010 were collected from administrative databases through health authorities and insurance. Antihistamines were reported in 109 cases of TdP/QT prolongation, 278 VA and 610 SCD/CA. Five agents resulted in stronger signals (cetirizine, desloratadine, diphenhydramine, fexofenadine, lorat...Continue Reading

References

Jan 1, 1991·Human & Experimental Toxicology·R A HendersonJ A Henry
Apr 24, 1999·British Journal of Clinical Pharmacology·F J de Abajo, L A Rodríguez
Jun 10, 2000·The British Journal of Dermatology·S DharG Mistri
Jul 13, 2000·Allergy and Asthma Proceedings·J A Grant
Nov 2, 2002·British Journal of Pharmacology·Constanze R SchererKlaus Steinmeyer
Apr 18, 2003·Pacing and Clinical Electrophysiology : PACE·Shaul AtarTiberio Rosenfeld
Dec 21, 2004·British Journal of Clinical Pharmacology·Michi WakaumiAkio Fujimura
Nov 10, 2005·The Journal of Pharmacology and Experimental Therapeutics·Alexander N KatchmanSteven N Ebert
Sep 25, 2007·European Journal of Clinical Pharmacology·Réginald HulhovenArmel Stockis
Feb 25, 2009·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Deborah LaytonSaad A W Shakir
Apr 10, 2009·Pharmacoepidemiology and Drug Safety·A Bate, S J W Evans
Apr 10, 2009·Pharmacoepidemiology and Drug Safety·Elisabetta PoluzziFabrizio De Ponti
Jul 22, 2009·European Journal of Clinical Pharmacology·Silvia RaveraJohan J de Gier
Mar 20, 2010·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Elisabetta PoluzziFabrizio De Ponti
Jun 16, 2011·Expert Review of Pharmacoeconomics & Outcomes Research·Kristina GaruolieneAlan Haycox
Nov 1, 2011·The Journal of Allergy and Clinical Immunology·F Estelle R Simons, Keith J Simons
Mar 13, 2012·British Journal of Clinical Pharmacology·Céline CailletUNKNOWN French Association of Regional Pharmacovigilance Centers
Apr 5, 2013·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Elisabetta PoluzziFabrizio De Ponti
Mar 20, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Keith B HoffmanBrian M Overstreet
Sep 27, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Keith B HoffmanColin B Erdman

❮ Previous
Next ❯

Citations

Oct 9, 2015·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Emanuel RaschiFabrizio De Ponti
Feb 20, 2019·Environmental Toxicology and Chemistry·Lisa BittnerNils Klüver
Sep 4, 2019·Cancer Chemotherapy and Pharmacology·Yulia VugmeysterHaiqing Dai
Jan 10, 2018·Medicinal Research Reviews·Přemysl MladěnkaUNKNOWN TOX-OER and CARDIOTOX Hradec Králové Researchers and Collaborators
Jul 1, 2017·Clinical and Experimental Allergy : Journal of the British Society for Allergy and Clinical Immunology·G K ScaddingA T Clark
Aug 11, 2020·Child Psychiatry and Human Development·Ingvild HoldøSvetlana Skurtveit
Oct 1, 2018·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Gianluca TrifiròGiovanni Corrao
Apr 22, 2018·Pharmacological Reports : PR·Ching-Hsia HungYu-Wen Chen
Jan 1, 2019·Current Epidemiology Reports·Nicole Pratt, Elizabeth Roughead
Dec 22, 2020·The World Allergy Organization Journal·Oliviero RossiElide Anna Pastorello
Mar 9, 2021·Journal of Cardiovascular Pharmacology and Therapeutics·Steven T SimonMichael A Rosenberg
Mar 12, 2021·Applied Clinical Informatics·Katy E TrinkleyMichael A Rosenberg
Apr 16, 2021·Frontiers in Cardiovascular Medicine·Saeideh Aghayari Sheikh NeshinRamin Zand
Jun 24, 2021·Case Reports in Cardiology·Mark CoyleMark Sheehy
Aug 11, 2021·British Journal of Clinical Pharmacology·Talip E ErogluUNKNOWN ESCAPE-NET Investigators
Nov 4, 2021·Allergy, Asthma, and Clinical Immunology : Official Journal of the Canadian Society of Allergy and Clinical Immunology·Eli O MeltzerLuiz Lucio

❮ Previous
Next ❯

Methods Mentioned

BETA
sedation

Software Mentioned

AZCERT

Related Concepts

Related Feeds

Birth Defects

Birth defects encompass structural and functional alterations that occur during embryonic or fetal development and are present since birth. The cause may be genetic, environmental or unknown and can result in physical and/or mental impairment. Here is the latest research on birth defects.

Anti-Arrhythmic Drug Therapies

Anti-arrhythmic drugs are used to prevent abnormal heart rhythms. These medications are used in conditions including, ventricular tachycardia, ventricular fibrillation and atrial fibrillation. Discover the latest research on anti-arrhythmic drug therapies here.

Allergy and Asthma

Allergy and asthma are inflammatory disorders that are triggered by the activation of an allergen-specific regulatory t cell. These t cells become activated when allergens are recognized by allergen-presenting cells. Here is the latest research on allergy and asthma.

Arrhythmia

Arrhythmias are abnormalities in heart rhythms, which can be either too fast or too slow. They can result from abnormalities of the initiation of an impulse or impulse conduction or a combination of both. Here is the latest research on arrhythmias.

Cardiotoxicity

Cardiotoxicity refers to the muscle damage or dysfunction of heart electrophysiology caused by drug intake or due to disease complications. It is a well-known side effect of several cytotoxic drugs, especially of the anthracyclines and can lead to long term morbidity. Here is the latest research.

Atrial Fibrillation

Atrial fibrillation is a common arrhythmia that is associated with substantial morbidity and mortality, particularly due to stroke and thromboembolism. Here is the latest research.