Omalizumab-associated anaphylactic reactions reported between January 2007 and June 2008

Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology
Robert Y LinGeeta A Bhargave

Abstract

Anaphylaxis associated with omalizumab treatment is a growing concern. The broader context in which omalizumab-associated allergic reactions occur has not been well described. To identify and characterize recently reported anaphylactic reactions associated with omalizumab administration. The US Food and Drug Administration Adverse Event Reporting System reports between January 1, 2007, and June 30, 2008, were queried for new reactions primarily suspected to be due to omalizumab. Reaction characteristics were analyzed for a reaction descriptor of anaphylactic or anaphylactoid shock or reaction and for dermal, respiratory, cardiovascular, and gastrointestinal reaction descriptor terms that in combination could be interpreted as constituting anaphylaxis. Associated narratives for these reports were obtained and were examined further. There were 85 cases with an anaphylaxis descriptor and 33 cases without a descriptor of anaphylaxis but with multisystem allergic reactions (mostly respiratory and skin or mucosal) that were consistent with anaphylaxis. Of these 118 cases, 32 were after the first dose and 14 were after the second dose of omalizumab. Seventy-seven of the 118 cases were categorized as requiring hospital admission or pro...Continue Reading

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Citations

Aug 25, 2011·Current Opinion in Immunology·Jeffrey R Stokes, Thomas B Casale
May 3, 2011·The Journal of Allergy and Clinical Immunology·Paul M O'Byrne
Apr 30, 2013·Expert Opinion on Biological Therapy·Priyanka Vashisht, Thomas Casale
May 25, 2016·Expert Opinion on Drug Safety·Giovanni PassalacquaGiorgio Walter Canonica
Jun 25, 2010·Current Opinion in Pharmacology·Shyam S MohapatraGary Hellermann
Dec 18, 2012·Current Opinion in Allergy and Clinical Immunology·Tara Shankar, Andrej A Petrov
Aug 14, 2010·Current Opinion in Allergy and Clinical Immunology·Marta RubioPascal Demoly
Sep 19, 2021·Expert Opinion on Drug Metabolism & Toxicology·Abimael González-HernándezCarlos M Villalón

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