Delayed onset and protracted progression of anaphylaxis after omalizumab administration in patients with asthma

Limb, Susan L. MD
Starke, Peter R. MD
Lee, Charles E. MD
Chowdhury, Badrul A. MD, PhD

Division of Pulmonary and Allergy Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Md

Disclosure of potential conflict of interest: The authors are employed by the US Food and Drug Administration.

The views expressed in this article are those of the authors and do not necessarily reflect the views or policies of the US Food and Drug Administration.

Available online October 15, 2007.

Reprint requests: Susan L. Limb, MD, US Food and Drug Administration, 10903 New Hampshire Avenue, Building 22, Room 3323, Silver Spring, MD 20993–0002. E-mail: [email protected]

Received for publication August 8, 2007; revised September 17, 2007; accepted for publication September 18, 2007.

Abbreviations used NIAID: National Institutes of Allergy and Infectious Disease; FAAN: Food Allergy and Anaphylaxis Network

Journal of Allergy & Clinical Immunology 120(6):p 1378-1381, December 2007.

Background

Risk of anaphylaxis is included in the prescribing information for omalizumab, but the nature of these reactions merits further elaboration.

Objective

To describe cases of anaphylaxis associated with omalizumab administration in patients with asthma.

Methods

We reviewed spontaneous postmarketing adverse event reports submitted to the US Food and Drug Administration's Adverse Event Reporting System database and to the manufacturers of omalizumab and cases published in the literature through December 2006. Diagnostic criteria for anaphylaxis outlined by the National Institute of Allergy and Infectious Diseases and the Food Allergy and Anaphylaxis Network were used to screen cases.

Results

One-hundred twenty-four cases of anaphylaxis associated with omalizumab administration in patients with asthma were identified. Many cases had a delayed onset of symptoms beyond 2 hours after dose administration. Many cases were also characterized by a protracted progression, with individual signs and symptoms of anaphylaxis staggered over hours. Review of the case reports did not reveal any predictive risk factors for the delayed onset or protracted progression of anaphylaxis.

Conclusion

Omalizumab-induced anaphylaxis may be characterized by a delayed onset and a protracted progression of symptoms.

Clinical implications

The unusual timing of anaphylaxis in these cases challenges our understanding of anaphylaxis. A delayed onset of symptoms and protracted progression of anaphylaxis should be taken into account when administering omalizumab.