The Journal of Allergy and Clinical Immunology
Volume 121, Issue 3 , Page 786, March 2008

Reply

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

Article Outline

 

To the Editor:

We thank Barry et al1 for highlighting some of the difficulties in evaluating omalizumab-induced anaphylaxis. We suspect that omalizumab-induced anaphylaxis might go unrecognized and underreported in the community for a variety of reasons, including atypical presentations, confounding atopic symptoms at baseline, and individual patient considerations, such as those described in their case report.

Such factors limit the accuracy of estimating event frequency on the basis of uncontrolled data. In our case series we relied primarily on postmarketing safety reports that are voluntarily submitted to the US Food and Drug Administration's Adverse Event Reporting System database. For other drug products and adverse events entered in this database, it is generally estimated that only 1% to 10% of all adverse events are ever reported.2, 3 Whether the same adjustment is applicable to omalizumab-induced anaphylaxis remains unclear at this time. As Barry et al1 point out, awareness on both the part of the physician and the part of the patient is necessary for expeditious management of these potentially severe reactions.

Back to Article Outline

References 

  1. Barry PJ, O'Mahony A, Finnegan C, O'Connor TM. Delayed allergic reactions to omalizumab: are patients reporting all cases?. J Allergy Clin Immunol. 2008;121:785–786
  2. Rogers AS, Israel E, Smith CR, Levine D, McBean AM, Valente C, et al. Physician knowledge, attitudes, and behavior related to reporting adverse drug events. Arch Intern Med. 1988;148:1596–1600
  3. Scott HD, Rosenbaum SE, Waters WJ, Colt AM, Andrews LG, Juergens JP, et al. Rhode Island physicians' recognition and reporting of adverse drug reactions. R I Med J. 1987;70:311–316

 Disclosure of potential conflict of interest: The authors have declared that they have no conflict of interest.

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

PII: S0091-6749(08)00132-2

doi:10.1016/j.jaci.2007.12.1187

The Journal of Allergy and Clinical Immunology
Volume 121, Issue 3 , Page 786, March 2008

Article Tools