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An evidence-based approach for providing cautionary recommendations to sulfonamide-allergic patients and determining cross-reactivity among sulfonamide-containing medications

1. S. Ghimire MPharm¹, 
2. E. Kyung PharmD MPharm¹, 
3. J. H. Lee MD PhD², 
4. J. W. Kim MD³, 
5. W. Kang PhD^4,*, 
6. E. Kim PharmD PhD^5,*

Article first published online: 13 MAR 2013

DOI: 10.1111/jcpt.12048

© 2013 Blackwell Publishing Ltd

Issue

Journal of Clinical Pharmacy and Therapeutics

Volume 38, Issue 3, pages 196–202, June 2013

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Keywords:

• adverse reactions;
• cross-reactivity;
• drug compendia;
• drug monograph;
• sulfonamide allergy and hypersensitivity;
• sulfonamide medications

Summary

What is known and Objective

Prescribing sulfonamide-containing medications for patients with sulfonamide allergy continues to complicate medical decisions. We examined the cautionary recommendations in the approved drug monographs and primary literature, and formulated an evidence-based grading of cautionary recommendations for sulfonamide allergy and cross-reactivity among sulfonamide-containing medications.

Methods

Drug monographs were collected from six countries and three drug compendia. Two reviewers independently extracted the data from the contraindication, warning and/or precaution sections of drug monographs. Evidence for cross-reactivity was examined in the primary literature and compared with drug monograph recommendations. Consequently, medications were categorized based on the strength of recommendation and level of evidence by consensus.

Results and Discussion

We identified wide variability in cautionary recommendations ranging from no warning or precaution to contraindication among the sources reviewed. The recommendations were located mainly in the contraindication section of monographs for France (65·2%), United Kingdom (51·9%), Italy (50·0%), South Korea (43·5%), United States (38·2%) and Canada (37·0%), whereas in drug compendia, the recommendations were found in the precaution section for Martindale (51·4%) and Micromedex-Drugdex (33·3%), and contraindication and precaution section for the American Hospital Formulary Service Drug Information 2010 (30·8%). Evidence from the primary literature varied with recommendation included in drug monographs. Evidence-based categorization was carried out for 16 medications. Two sulfonamide-moiety-containing drugs were considered safe, six non-sulfonylarylamines required precaution, and eight medications from all three sulfonamide chemical classes were considered mostly unsafe.

What is new and Conclusion

There are significant discrepancies in cautionary recommendations included in drug-labels and drug compendia. Statements concerning cross-reactive hypersensitivity with other sulfonamides generally suggest theoretical possibilities. The consensus evidence-based grading instrument developed may be useful for deriving cautionary recommendations for sulfonamide-allergic patients.

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Skin Test–Positive Immediate Hypersensitivity Reaction to Iodinated Contrast Media: The Role of Controlled Challenge Testing

Skin Test–Positive Immediate Hypersensitivity Reaction to Iodinated Contrast Media: The Role of Controlled Challenge Testing

A Prieto-García, M Tomás, R Pineda, P Tornero, T Herrero, V Fuentes, L Zapatero, M de Barrio

Allergy Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain

J Investig Allergol Clin Immunol 2013; Vol. 23(3): 183-189

Abstract Background: Immediate hypersensitivity reactions (IHR) to iodinated contrast media (ICM) have traditionally been considered nonallergic; however, the increasingly frequent reporting of positive skin test and basophil activation test results suggests a specific allergic mechanism in some patients. Skin tests have been proposed as a useful tool for diagnosis, although their sensitivity and predictive values remain to be determined. The role of controlled challenge testing has not been assessed. Objective: We aimed to evaluate the role of controlled challenge testing in skin test–positive IHR to ICM. Patients and Methods: We evaluated 106 patients with IHR to ICM by performing skin tests with the agent that caused the reaction. Patients with a positive result were selected. Skin tests were extended to a series of 8 ICMs; 5 patients underwent controlled challenge test with an alternative skin test–negative ICM; a further 2 patients underwent computed tomography with an alternative skin test–negative ICM. No premedication was administered. Results: Intradermal test results were positive to the ICM that caused the reaction in 11 out of 106 patients (10.4%). Five of the 11 patients tolerated a controlled challenge test with an alternative skin test–negative ICM. The 2 patients who underwent computed tomography with an alternative skin test–negative ICM tolerated the medium. Conclusions: Skin tests are useful for the diagnostic workup in patients with an allergic IHR to ICM. Since ICM cannot be avoided in many patients because they are irreplaceable in some diagnostic or therapeutic techniques, an alternative safe ICM should be investigated for future procedures. We propose the use of controlled challenge tests based on skin test results to address this need in skin test–positive reactions in order to identify an alternative non–cross-reactive ICM. Key words: Controlled challenge test. Allergic immediate hypersensitivity reactions. Iodinated contrast media. Skin tests.   Free Full-Text (PDF)   How to use PDF documents

Prevalence of Subjective Olfactory Dysfunction and Its Risk Factors

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RESEARCH ARTICLE

Prevalence of Subjective Olfactory Dysfunction and Its Risk Factors: Korean National Health and Nutrition Examination Survey

• Woo Hyun Lee,
 
• Jee Hye Wee,
 
• Dong-Kyu Kim,
 
• Chae-Seo Rhee,
 
• Chul Hee Lee,
 
• Soyeon Ahn,
 
• Ju Hyun Lee,
 
• Yang-Sun Cho,
 
• Kun Hee Lee,
• Kyung Soo Kim,
 
• Si Whan Kim,
 
• Ari Lee,
 
• Jeong-Whun Kim mai

Abstract

Background

Population-based studies for olfactory dysfunction are lacking. The aim of this study is to evaluate the prevalence of subjective olfactory dysfunction and its risk factors in the Korean general population.

Methods

The data were obtained from the 2009 Korea National Health and Nutrition Examination Survey (KNHANES), which was a cross-sectional survey of non-institutionalized population all around the country (n = 10,533). All interviewees underwent medical interviews, physical examinations, endoscopic examination and blood/urine tests. Whether sense of smell has been normal or abnormal during the last 3 months was asked. Complete olfaction data were obtained from 7,306 participants and the participants were divided into normosmic and hyposmic group. Multivariate logistic regression analyses were performed to identify its risk factors.

Results

The weighted prevalence of subjective olfactory dysfunction was 4.5%. Its increased prevalence was significantly associated with the increasing age for both men and women. In the multivariate analyses, low income (adjusted odds ratio [OR] = 1.43, 95% Confidence Interval [CI] = 1.01–2.03), habitual exposure to air pollutants (adjusted OR = 2.18, CI = 1.33–3.55), a history of hepatitis B (adjusted OR = 3.10, CI = 1.25–7.68), rhinitis (adjusted OR = 1.78, CI = 1.26–2.51) and chronic sinusitis (adjusted OR = 14.55, CI = 10.06–21.05) were risk factors of olfactory dysfunction.

Conclusion

Our population-based study showed that olfactory dysfunction was quite prevalent and several risk factors were associated with impaired sense of smell. Given its prevalence, further researches for its prevention and management are required.

Citation: Lee WH, Wee JH, Kim D-K, Rhee C-S, Lee CH, et al. (2013) Prevalence of Subjective Olfactory Dysfunction and Its Risk Factors: Korean National Health and Nutrition Examination Survey. PLoS ONE 8(5): e62725. doi:10.1371/journal.pone.0062725

Editor: Yiqing Song, Brigham & Women's Hospital, and Harvard Medical School, United States of America

Received: January 8, 2013; Accepted: March 25, 2013; Published: May 9, 2013

Copyright: © 2013 Lee et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: The authors have no support or funding to report.

Competing interests: The authors have declared that no competing interests exist.

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Efficacy of bepotastine besilate ophthalmic solution 1.5% for seasonal allergic conjunctivitis.

 Allergy and Asthma Proceedings, Volume 34, Number 3

 Efficacy of bepotastine besilate ophthalmic solution 1.5% for seasonal allergic conjunctivitis: A randomized, placebo-controlled, natural exposure, clinical trial

Authors: Carr, Warner W.; Nayak, Anjuli S.; Ratner, Paul H.; Gow, James A.; McNamara, Timothy R.; Williams, Jon I.; for the Bepotastine Besilate Ophthalmic Solution 1.5 Bepreve Study Group,

Source: Allergy and Asthma Proceedings, Volume 34, Number 3, May/June 2013 , pp. 247-254(8)

Publisher: OceanSide Publications, Inc

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Abstract:

Allergic conjunctivitis (AC) affects an estimated 20% of the population in the Western world, with a large fraction suffering due to seasonal or perennial allergen exposures. Bepotastine besilate ophthalmic solution (BBOS) 1.5%, a dual-acting histamine (H₁) receptor antagonist and mast cell stabilizer, is indicated for itching associated with AC. This study was designed to evaluate the efficacy and safety of BBOS 1.5% for reducing ocular itching associated with AC in subjects enrolled in a natural exposure trial. Eligible subjects in a multicenter, double-masked, randomized, parallel-group, placebo-controlled, natural exposure clinical trial were randomly assigned to either BBOS 1.5% or placebo eyedrops on a 1:1 basis and instilled 1 drop of the test agent into both eyes twice daily for 2 weeks. The mean change from baseline in instantaneous and reflective ocular itching scores at the end of 2 weeks of treatment were evaluated based on subject-assessed severity of instantaneous and reflective itching. Subject-reported adverse events (AEs) were also recorded for safety. Treatment with BBOS 1.5% significantly reduced instantaneous and reflective ocular itching scores from baseline compared with placebo over the 2-week study period (p = 0.007 and p = 0.005, respectively). BBOS 1.5% was well tolerated, and AEs were generally transient and mild. This clinical study indicates BBOS 1.5% effectively and safely treated ocular itching in a natural exposure allergy study and is a useful treatment option for the management of ocular itching associated with AC. (ClinicalTrials.gov identifier number: NCT01174823.)

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Keywords: Allergy; bepotastine besilate; clinical trial; environmental study; histamine receptor antagonist; immunoglobulin E;mast cell degranulation; ocular itching; placebo control; seasonal allergic conjunctivitis

Document Type: Research article

DOI: http://dx.doi.org/10.2500/aap.2013.34.3671

Affiliations: 1: Allergy and Allergy Associates of Southern California, Mission Viejo, California, USA

Publication date: 2013-05-01

Summary

Expert Review of Clinical Immunology

May 2013, Vol. 9, No. 5, Pages 465-475 , DOI 10.1586/eci.13.25

(doi:10.1586/eci.13.25)

Review

  

A comparison of immunotherapy delivery methods for allergen immunotherapy

Ludger Klimek^* and Oliver Pfaar

* Author for correspondence

Background: Allergic diseases are among the most common diseases in humans. Besides allergen avoidance, allergen-specific immunotherapy is the only causative treatment option. During recent years, many innovations of this therapy have emerged. Methods: Selective literature research in Medline and PubMed, under the inclusion of national and international guidelines and Cochrane meta analyses. Results: In several meta-analyses, the clinical efficacy of subcutaneous immunotherapy (SCIT) has been largely demonstrated. Recently, major research activities in mucosal immunotherapies focused on the sublingual application route. There are well-documented clinical data on the efficacy and safety of this form of immunotherapy. New application routes as well as new immune-modifying agents such as virus-like particles or CpG-motifs have also been investigated. Conclusion: SIT is accepted to be the only causative treatment option for allergies. New application routes and new immune-modifying agents will allow for different delivery methods in the future.

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Asthma Phenotypes and Endotypes: An Evolving Paradigm for Classification

In a collaboration betweenDiscovery Medicine and Johns Hopkins School of Medicine CME, certain articles published byDiscovery Medicine will be certified by Johns Hopkins as a Johns Hopkins CME series. These articles will be labeled "Hopkins CME."

Article Published in the Author Account of

Jonathan Corren

Asthma Phenotypes and Endotypes: An Evolving Paradigm for Classification

Published on April 26, 2013

Author: Jonathan Corren

Specialty: Immunology, Internal Medicine
Institution: Department of Medicine, University of California, Los Angeles
Address: 10780 Santa Monica Blvd., Suite 280, Los Angeles, California, 90025, United States

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Abstract: Asthma is a common chronic disease characterized by intermittent chest symptoms, variable airways obstruction, and bronchial hyperresponsiveness. Research performed over the past one to two decades has sought to better understand the heterogeneous clinical nature of asthma. Whereas older attempts at phenotyping asthma emphasized the duality of allergic vs. non-allergic asthma, more recent non-biased analyses have attempted to cluster patients by a multitude of possible features, including age of onset, atopy, severity of airways obstruction, and requirement for medication. Examples of these phenotypes include early-onset mild allergic asthma, later-onset asthma associated with obesity, and severe non-atopic asthma with frequent exacerbations. The elucidation of asthma phenotypes has been further refined by including information regarding pathophysiologic mechanisms present in different groups. These groups, called endotypes, include examples such as aspirin-exacerbated respiratory disease and allergic bronchopulmonary mycosis. A growing understanding of these mechanistically distinct groups, along with the identification of relevant cellular or molecular biomarkers, is already showing promise as a way of predicting clinical response to various asthma therapies. As the number of targeted treatments for asthma continues to grow, physicians will have the opportunity to practice an individualized approach to diagnosis and treatment, which will hopefully improve asthma outcomes and quality of life for these patients.

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EDUCATIONAL OBJECTIVE: Readers will consider the diagnosis of hereditary angioedema if a patient has recurrent attacks of angioedema that do not respond to usual therapy

Recognizing and managing hereditary angioedema

1. KEVIN TSE, MD

1. Division of Rheumatology, Allergy, and Immunology, Department of Medicine, University of California San Diego, La Jolla

1. BRUCE L. ZURAW, MD⇑

+Author Affiliations

1. Division of Rheumatology, Allergy, and Immunology, Department of Medicine, University of California San Diego, La Jolla; San Diego Veterans Administration Healthcare, San Diego, CA

1. ADDRESS: Bruce Zuraw, MD, Division of Rheumatology, Allergy, and Immunology, Department of Medicine, University of California San Diego, 9500 Gilman Drive, Mailcode 0732, La Jolla, CA 92093; e-mail: bzuraw@ucsd.edu

 

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Abstract

Hereditary angioedema is a rare but life-threatening disease characterized by recurring attacks of swelling of any part of the body, without hives. Prompt recognition is critical so that treatment can be started to minimize morbidity and the risk of death. Drugs have recently become available to prevent and treat acute attacks.

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Key points

Swelling in the airways is life-threatening and requires rapid treatment.

Almost half of attacks involve the abdomen, and abdominal attacks account for many emergency department visits, hospitalizations, and unnecessary surgical procedures for acute abdomen.

Acute attacks can be managed with plasma-derived or recombinant human preparations of C1 inhibitor (which is the deficient factor in this condition), ecallantide (a specific plasma kallikrein inhibitor), or icatibant (a B2 bradykinin receptor antagonist).

Short-term prophylaxis may be used before events that could provoke attacks (eg, dental work or surgery). Long-term prophylaxis may be used in patients who have frequent or severe attacks or require more stringent control of their disease. Plasma-derived C1 inhibitor is both safe and effective when used as prophylaxis. Attenuated androgens are effective but associated with many adverse effects.

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Vitamin D, the Cutaneous Barrier, Antimicrobial Peptides and Allergies: Is There a Link?

Review  Open Access

|    Allergy Asthma Immunol Res. 2013 May;5(3):119-128. English. Published online 2013 February 04.  http://dx.doi.org/10.4168/aair.2013.5.3.119  Copyright © 2013 The Korean Academy of Asthma, Allergy and Clinical Immunology • The Korean Academy of Pediatric Allergy and Respiratory Disease Vitamin D, the Cutaneous Barrier, Antimicrobial Peptides and Allergies: Is There a Link? Elisabeth Roider, Thomas Ruzicka and Jürgen Schauber Department of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany.  Correspondence to: Jürgen Schauber, MD, Department of Dermatology and Allergy, Ludwig-Maximilian University, Frauenlobstr. 9-11, 80337 Munich, Germany. Tel: +49-89-5160-6388; Fax: +49-89-5160-6389; Email:juergen.schauber@med.uni-muenchen.de  Received August 21, 2012; Accepted October 10, 2012. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract Atopic diseases such as atopic dermatitis (AD) are very common in industrialized countries. Up to 15%-30% of all children and 2%-10% of all adults suffer from AD. Already in early disease stages, a defective epidermal barrier is known to contribute to the pathogenesis of AD. Central elements in the epidermal barrier are antimicrobial peptides (AMPs), which are secreted by keratinocytes, sweat gland cells but also infiltrating immune cells. AMPs function as endogenous antibiotics and are able to kill bacteria, viruses, and fungi. Furthermore AMPs act as immune modulators with effects on the innate and adaptive immune system. The probably best studied AMPs in human skin are the defensins and cathelicidin. In atopic diseases the functions of AMPs such as cathelicidin might be impaired and microbial superinfections could serve as cofactors for allergic sensitization. Hence, induction of AMPs could be beneficial in these patients. Cathelicidin which is often referred to its peptide form hCAP18 or LL-37 can be induced by ultraviolet light B (UVB) irradiation and is upregulated in infected and injured skin. The cathelicidin gene carries a vitamin D response element and the vitamin D pathway could therefore be targeted for cathelicidin regulation. As the development and course of atopic diseases might be influenced by vitamin D signaling these pathomechanisms could explain the growing evidence connecting vitamin D to allergic diseases, including AD, allergic rhinitis, food allergies and asthma. In this review the role of vitamin D and the AMP cathelicidin in the pathogenesis of atopic diseases with impaired barrier function will be discussed. Keywords: Vitamin D, atopic dermatitis, allergy, cutaneous barrier, antimicrobial peptides, cathelicidin.