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Guideline Summary
Guideline Title
Guidelines for the diagnosis and management of food allergy in the United States.
Bibliographic Source(s)
Boyce JA, Assa'ad A, Burks AW, Jones SM, Sampson HA, Wood RA, Plaut M, Cooper SF, Fenton MJ, NIAID-Sponsored Expert Panel, Arshad SH, Beck LA, Byrd-Bredbenner C, Camargo CA Jr, Eichenfield L, Furuta GT, Hanifin JM, Jones C, Kraft M, Levy BD, Lieberman P, Luccioli S, McCall KM, Schneider LC, Simon RA, Simons FE, Teach SJ, Yawn BP, Schwaninger JM. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol. 2010 Dec;126(6 Suppl):S1-58. [347 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Food allergy (FA)

Guideline Category
Counseling
Diagnosis
Evaluation
Management
Prevention
Risk Assessment
Treatment
Clinical Specialty
Allergy and Immunology
Critical Care
Dermatology
Emergency Medicine
Family Practice
Gastroenterology
Internal Medicine
Nursing
Nutrition
Pediatrics
Preventive Medicine
Pulmonary Medicine
Intended Users
Advanced Practice Nurses
Emergency Medical Technicians/Paramedics
Health Care Providers
Nurses
Physician Assistants
Physicians
Guideline Objective(s)
  • To provide concise recommendations to a wide variety of health care professionals on how to diagnose food allergy (FA), manage ongoing FA, and treat acute FA reactions
  • To identify and provide guidance on points of current controversy in patient management
Target Population

Patients (infants, children and adults) with food allergy (FA) or suspected of having FA

Note: The Guidelines focus on diseases that are defined as FA and include both immunoglobulin E (IgE)-mediated reactions to food and some non-IgE-mediated reactions to food. The Guidelines do not discuss celiac disease, which is an immunologic non-IgE-mediated reaction to certain foods.

These Guidelines do not address the management of patients with FA outside of clinical care settings (for example, schools and restaurants) or the related public health policy issues.

Interventions and Practices Considered

Diagnosis of Food Allergy

  1. Recognition of symptoms of food allergy
  2. Medical history
  3. Physical examination
  4. Skin prick test
  5. Total serum immunoglobulin E (IgE)
  6. Allergen-specific serum IgE
  7. Atopy patch test
  8. Food elimination diets
  9. Oral food challenges

Note: The following diagnostic tests were considered but not recommended for the routine evaluation of IgE-mediated food allergy: intradermal tests, basophil histamine release/activation, lymphocyte stimulation, facial thermography, gastric juice analysis, endoscopic allergen provocation, hair analysis, applied kinesiology, provocation neutralization, allergen-specific immunoglobulin G4 (IgG4), cytotoxicity assays, electrodermal test (Vega), mediator release assay (LEAP diet)

Management of Nonacute Allergic Reactions and Prevention of Food Allergy

  1. Dietary avoidance of the specific allergen or allergens
  2. Nutritional counseling
  3. Regular growth monitoring for children with food allergy
  4. Vaccinations in patients with egg allergies
  5. Testing for food allergies in high-risk populations
  6. Maternal diet during lactation
  7. Breast feeding
  8. Use of hydrolyzed infant formulas
  9. Timing of introduction of allergenic foods to infants

Note: Immunotherapy and use of soy-based infant formulas to prevent food allergies were considered but not recommended.

Management of Anaphylaxis

First-Line Treatment

Epinephrine, intramuscular (IM)

Adjunctive Treatment

  1. Bronchodilator (β2-agonist): albuterol
  2. H1 antihistamine: diphenhydramine
  3. Supplemental oxygen therapy
  4. IV fluids in large volumes
  5. Patient in recumbent position if tolerated
  6. H2 antihistamine: ranitidine
  7. Corticosteroids: prednisone or methylprednisolone
  8. Vasopressors (other than epinephrine) for refractory hypotension
  9. Glucagon for refractory hypotension
  10. Atropine for bradycardia

Therapy at Discharge

  1. Epinephrine auto-injector prescription (2 doses) and instructions
  2. Adjunctive treatments (H1 and H2 antihistamines, corticosteroids)
  3. Education on avoidance of allergen
  4. Follow-up with primary care physician
  5. Consider referral to an allergist
Major Outcomes Considered
  • Sensitivity/specificity of diagnostic tests
  • Accuracy of diagnosis
  • Morbidity and mortality
  • Quality of life

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

RAND Corporation prepared an independent, systematic literature review and evidence report on the state of the science in food allergy (FA) (see "Availability of Companion Documents" field).

The National Institute of Allergy and Infectious Diseases (NIAID) and the Expert Panel (EP) developed an extensive set of key questions, which were further refined in discussions with RAND. Literature searches were performed on PubMed, Cochrane Database of Systematic Reviews, Cochrane Database of Abstracts of Reviews of Effectiveness, Cochrane Central Register of Controlled Trials, and the World Allergy Organization Journal, a relevant journal that is not included in PubMed. In most cases, searches were limited to the years 1988 (January) to 2009 (September), with no language restrictions. Additional publications identified by the EP and others involved in the review process also were included in the RAND review if and only if they met the RAND criteria for inclusion.

RAND researchers screened all titles found through searches, as well as those that were submitted by the EP or NIAID. Screening criteria were established to facilitate the identification of articles concerning definitions, diagnoses, prevention, treatment, management, and other topics. Articles were included or excluded based on article type and study purpose as follows:

  • Article type
    • Included: Original research or systematic reviews
    • Excluded: Background or contextual reviews; nonsystematic reviews; commentary; other types of articles
  • Study purpose
    • Included: Incidence/prevalence/natural history; diagnosis; treatment/management/prevention
    • Excluded: Not about FA; about some aspect not listed in the "included" category
Number of Source Documents

RAND screened more than 12,300 titles, reviewed more than 1,200 articles, abstracted nearly 900 articles, and included 348 articles in the final RAND report.

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, RAND provided a grade of high, moderate, or low as a measure of the quality of evidence, according to the following criteria:

  • High—Further research is very unlikely to have an impact on the quality of the body of evidence, and therefore the confidence in the recommendation is high and unlikely to change.
  • Moderate—Further research is likely to have an impact on the quality of the body of evidence and may change the recommendation.
  • Low—Further research is very likely to have an important impact on the body of evidence and is likely to change the recommendation.

Note: A GRADE designation of "Low" for the quality of evidence does not imply that an article is not factually correct or lacks scientific merit. For example, a perfectly designed and executed study of a treatment in a small sample that is from a single site of highly selected patients might still yield an overall GRADE of "Low." This is because a single small study is characterized as "sparse" data, and the patient population may not be representative of the larger population of patients with food allergies. Each of these factors reduces the level of evidence from "High," which is how randomized controlled trial (RCT) evidence is designated initially. It is worth emphasizing that these 2 limitations are not of the study per se, but of the body of evidence. Replication of the study's result on other populations would result in a GRADE of "High." It should be noted that the Expert Panel recommendations made in these Guidelines are often based on a GRADE classification of the quality of evidence as "Low," thus necessitating more contribution to the recommendation from expert opinion. For additional information to understand the concept of "quality of the body of evidence," please see Appendix C of the original guideline document.

Methods Used to Analyze the Evidence
Systematic Review
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

Two RAND investigators independently reviewed all titles and abstracts to identify potentially relevant articles. Articles that met the inclusion criteria were independently abstracted by a single RAND investigator. Because of the large number of articles and the short time for the review, articles were not independently abstracted by 2 RAND investigators (dual-abstracted). However, team members worked together closely and data were double-checked. Selected conclusions from the report have been published in a peer-reviewed journal, and the full version of the report with a complete list of references is available (see "Availability of Companion Documents" field).

Assessing the Quality of the Body of Evidence

For each key question, in addition to assessing the quality of each of the included studies, RAND assessed the quality of the body of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, which was developed in 2004. GRADE provides a comprehensive and transparent methodology to develop recommendations for the diagnosis, treatment, and management of patients. In assessing the body of evidence, GRADE considers study design and other factors, such as the precision, consistency, and directness of the data. Using this approach, GRADE then provides a grade for the quality of the body of evidence.

Based on the available scientific literature on food allergies, which in some areas was minimal, RAND used the GRADE approach to assess the overall quality of evidence for each key question assigned by the Expert Panel (EP) and assigned a grade (see "Rating Scheme for the Strength of the Evidence").

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

The Coordinating Committee

The National Institute of Allergy and Infectious Diseases (NIAID) established a Coordinating Committee (CC) to oversee the development of the Guidelines; review drafts of the Guidelines for accuracy, practicality, clarity, and broad utility of the recommendations in clinical practice; review the final Guidelines; and disseminate the Guidelines. The CC members were from 34 professional organizations, advocacy groups, and federal agencies.

The Expert Panel

The CC convened an Expert Panel (EP) in March 2009. Panel members were specialists from a variety of relevant clinical, scientific, and public health areas.

The charge to the EP was to use an independent, systematic literature review, in conjunction with consensus expert opinion and EP-identified supplementary documents, to develop Guidelines that provide a comprehensive approach for diagnosing and managing FA based on the current state of the science.

Preparation of Draft Guidelines and Expert Panel Deliberations

The EP prepared a draft version of the Guidelines based on the RAND evidence report and also supplementary documents that were identified by the EP but not included in the RAND report (see "Availability of Companion Documents" field).

The supplementary documents contained information of significant value that was not included in the systematic literature review due to the objective criteria for inclusion or exclusion established by RAND, such as limits on demographics, study population size, and study design. The EP used this additional information only to clarify and refine conclusions drawn from sources in the systematic literature review.

It also should be noted that included references are illustrative of the data and conclusions discussed in each section, and do not represent the totality of relevant references. For a full list of relevant references, the reader should refer to the full version of the RAND report (see "Availability of Companion Documents" field).

In October 2009, the EP discussed the first written draft version of the Guidelines and their recommendations. Following the meeting, the EP incorporated any panel-wide changes to the recommendations within the draft Guidelines. These revised recommendations were then subject to an initial panel-wide vote to identify where panel agreement was less than 90%. Controversial recommendations were discussed via teleconference and e-mail to achieve group consensus. Following discussion and revision as necessary, a second vote was held. All recommendations that received 90% or higher agreement were included in the draft Guidelines for public review and comment.

In addition to the 43 recommendations, sections 3, 5, and 6 of the Guidelines contain "In summary" statements. These statements are intended to provide health care professionals with significant information that did not warrant a recommendation, or are in place of a recommendation when the EP or the CC could not reach consensus. All "In summary" statements received 90% or higher agreement.

Rating Scheme for the Strength of the Recommendations

The Expert Panel (EP) has used the verb "recommends" or "suggests" in each clinical guideline. These words convey the strength of the guideline, defined as follows:

  • Recommend is used when the EP strongly recommended for or against a particular course of action.
  • Suggest is used when the EP weakly recommended for or against a particular course of action.
Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

Public Comment Period and Draft Guidelines Revision

The draft Guidelines were posted to the National Institute of Allergy and Infectious Diseases (NIAID) Web site in March 2010 for a period of 60 days to allow for public review and comment. More than 550 comments were collected and reviewed by the Coordinating Committee (CC), the Expert Panel (EP), and NIAID. The EP revised the Guidelines in response to some of these comments.

Further deliberation between the CC and the EP resulted in the revision of 5 recommendations. In addition, section 5.1.11 of the original guideline, which discusses vaccination in patients with allergy to hen's egg, also underwent substantial revision to bring it into better alignment with national vaccine policies. Consequently, the EP developed 1 recommendation for vaccination with measles, mumps, and rubella (MMR) and measles, mumps, rubella, and varicella (MMRV), and 3 "In summary" statements for influenza, yellow fever, and rabies vaccinations. All new recommendations and "In summary" statements were subjected to a panel-wide vote and achieved 90% consensus or more. The final Guidelines were reviewed by the CC.

Recommendations

Major Recommendations

Definitions for the quality of evidence (high, moderate, low) and the strength of each clinical guideline (use of the verb "recommends" or suggests") are provided at the end of the "Major Recommendations."

Diagnosis of Food Allergy

When Should Food Allergy Be Suspected?

Guideline 1: The expert panel (EP) recommends that food allergy (FA) should be considered:

  • In individuals presenting with anaphylaxis or any combination of symptoms listed in the table below that occur within minutes to hours of ingesting food, especially in young children and/or if symptoms have followed the ingestion of a specific food on more than 1 occasion
  • In infants, young children, and selected older children diagnosed with certain disorders, such as moderate to severe atopic dermatitis (AD), eosinophilic esophagitis (EoE), enterocolitis, enteropathy, and allergic proctocolitis (AP)
  • In adults diagnosed with EoE

Rationale: Sufficient evidence exists to support the evaluation of FA in patients presenting with specific allergic signs and symptoms following the ingestion of food or with certain disorders frequently associated with allergic reactions to food, even in some cases without an apparent relationship to eating.

Balance of benefits and harms: Identification and avoidance of foods responsible for food-induced allergic reactions improve quality of life and potentially prevent life-threatening reactions and disorders. With the appropriate evaluation, there is a low risk of erroneously diagnosing someone as food allergic and adversely affecting his or her nutritional well-being and social interactions.

Quality of evidence: Moderate

Contribution of expert opinion: Significant

Table. Symptoms of Food-induced Allergic Reactions

Target Organ Immediate Symptoms Delayed Symptoms
Cutaneous Erythema
Pruritus
Urticaria
Morbilliform eruption
Angioedema
Erythema
Flushing
Pruritus
Morbilliform eruption
Angioedema
Eczematous rash
Ocular Pruritus
Conjunctival erythema
Tearing
Periorbital edema
Pruritus
Conjunctival erythema
Tearing
Periorbital edema
Upper respiratory Nasal congestion
Pruritus
Rhinorrhea
Sneezing
Laryngeal edema
Hoarseness
Dry staccato cough
 
Lower respiratory Cough
Chest tightness
Dyspnea
Wheezing
Intercostal retractions
Accessory muscle use
Cough, dyspnea, and wheezing
Gastrointestinal (GI) (oral) Angioedema of the lips, tongue, or palate
Oral pruritus
Tongue swelling
 
GI (lower) Nausea
Colicky abdominal pain
Reflux
Vomiting
Diarrhea
Nausea
Abdominal pain
Reflux
Vomiting
Diarrhea
Hematochezia
Irritability and food refusal with weight loss (young children)
Cardiovascular Tachycardia (occasionally bradycardia in anaphylaxis)
Hypotension
Dizziness
Fainting
Loss of consciousness
 
Miscellaneous Uterine contractions
Sense of "impending doom"
 

Diagnosis of IgE-Mediated Food Allergy

Medical History and Physical Examination

Guideline 2: The EP recommends using medical history and physical examination to aid in the diagnosis of FA.

  • Medical history: The EP recommends using a detailed medical history to help focus the evaluation of an FA. Although the medical history often provides evidence for the type of food-induced allergic reaction and the potential causative food(s) involved, history alone cannot be considered diagnostic of FA.
  • Physical examination: The EP recommends performing a focused physical examination of the patient, which may provide signs consistent with an allergic reaction or disorder often associated with FA. However, by itself, the physical examination cannot be considered diagnostic of FA.

Rationale: Medical history is useful for identifying food allergens that may be responsible for immunoglobulin E (IgE)-mediated allergic reactions, but it lacks sufficient sensitivity and specificity to definitively make a diagnosis of FA. Moreover, medical history is more useful in diagnosing immediate food-induced allergic reactions compared with delayed reactions. Further evaluation, for example laboratory studies or oral food challenges, is required to confirm a diagnosis of FA.

Balance of benefits and harms: The medical history and physical examination provide evidence for suspecting FA and focus the evaluation. However, basing the diagnosis of FA on either history or physical examination alone may lead to an erroneous diagnosis of FA and unnecessarily restrictive diets that could have adverse nutritional and social consequences.

Quality of evidence: Low

Contribution of expert opinion: Significant

Guideline 3: The EP recommends that parent and patient reports of FA must be confirmed, because multiple studies demonstrate that 50% to 90% of presumed FAs are not allergies.

Rationale: Given the low positive predictive value of self-reported symptoms, it is important that all suspected FA be confirmed by appropriate evaluation (for example, oral food challenge or tests for allergic sensitization).

Balance of benefits and harms: Because unnecessary food avoidance affects quality of life and nutrition, there is possible harm in over-diagnosing FA.

Quality of evidence: High

Contribution of expert opinion: Minimal

Methods to Identify the Causative Food

Skin Prick Test

Guideline 4: The EP recommends performing an SPT (skin prick test; also known as a skin puncture test) to assist in the identification of foods that may be provoking IgE-mediated food-induced allergic reactions, but the SPT alone cannot be considered diagnostic of FA.

Rationale: SPTs are safe and useful for identifying foods potentially provoking IgE-mediated food-induced allergic reactions, but they have a low positive predictive value for the clinical diagnosis of FA.

Balance of benefits and harms: The reagents and methods for performing SPTs are not standardized. Nevertheless, SPTs effectively detect the presence of allergen-specific IgE (sIgE), but many patients have sIgE without clinical FA. Compared with oral food challenges, SPTs have low specificity and low positive predictive value for making an initial diagnosis of FA. Thus, use of SPTs in the clinical setting may lead to over-diagnosis. However, in a patient with confirmed FA, an SPT is valuable in identifying the food(s) responsible for IgE-mediated FA. In the clinical setting, when compared with oral food challenges, SPTs have high sensitivity and high negative predictive values.

Quality of evidence: Moderate

Contribution of expert opinion: Significant

Intradermal Tests

Guideline 5: The EP recommends that intradermal testing should not be used to make a diagnosis of FA.

Rationale: Insufficient evidence exists to support the use of intradermal testing for the diagnosis of FA. Moreover, intradermal tests carry a higher risk of adverse reactions than SPTs.

Balance of benefits and harms: Although intradermal testing may be more sensitive than skin prick testing for the diagnosis of IgE-mediated FA, there is no evidence to support such claims for protein-induced FA and insufficient evidence to support its routine use in diagnosing carbohydrate-induced FA. In addition, there is a greater risk of systemic adverse allergic reactions from intradermal tests compared with SPTs.

Quality of evidence: Low

Contribution of expert opinion: Significant

Total Serum IgE

Guideline 6: The EP recommends that the routine use of measuring total serum IgE should not be used to make a diagnosis of FA.

Rationale: Insufficient evidence exists to support the proposal that measurements of total serum IgE levels can be a sensitive and specific test for FA.

Balance of benefits and harms: Although an elevated total serum IgE level is frequently found in atopic individuals and some investigators suggest that it may be useful when interpreting sIgE levels, the EP could find no studies to support such a claim. In addition, the sensitivity and specificity of this test compared with the outcome of oral food challenges is insufficient to warrant routine use in evaluating FA.

Quality of evidence: Low

Contribution of expert opinion: Significant

Allergen-Specific Serum IgE

Guideline 7: The EP recommends sIgE tests for identifying foods that potentially provoke IgE-mediated food-induced allergic reactions, but alone these tests are not diagnostic of FA.

Rationale: sIgE tests are useful for identifying foods potentially provoking IgE-mediated food-induced allergic reactions, and specified "cutoff" levels, defined as 95% predictive values, may be more predictive than SPTs of clinical reactivity in certain populations, but when used alone they are not diagnostic of FA.

Balance of benefits and harms: sIgE tests are very useful for detecting the presence of sIgE antibodies, which indicates the presence of allergic sensitization. Fluorescence-labeled antibody assays have comparable sensitivity to that of SPTs, and the absolute levels of sIgE antibodies may directly correlate with the likelihood of clinical reactivity when compared with oral food challenges for the identification of foods provoking IgE mediated FA.

Quality of evidence: Moderate

Contribution of expert opinion: Significant

Atopy Patch Test

Guideline 8: The EP suggests that the atopy patch test (APT) should not be used in the routine evaluation of non-contact FA.

Rationale: Insufficient evidence exists to support the use of the APT for the evaluation of FA.

Balance of benefits and harms: Although a number of studies have reported that the APT may be useful in the evaluation of FA in patients with AD and EoE, there is no agreement on the appropriate reagents, methods, or interpretation of these tests. When compared with oral food challenges, APTs show highly variable sensitivity and specificity among different studies.

Quality of evidence: Low

Contribution of expert opinion: Significant

Use of Skin Prick Tests, sIgE Tests, and Atopy Patch Tests in Combination

Guideline 9: The EP suggests not using the combination of SPTs, sIgE tests, and APTs for the routine diagnosis of FA.

Rationale: No literature supports the proposal that the use of SPTs, sIgE tests, and APTs in combination for the evaluation of FA provides any significant advantage over the use of SPTs or sIgE tests alone.

Balance of benefits and harms: Combining the results of SPTs, sIgE tests, and APTs may provide higher positive and negative predictive values than any test alone, but use of all 3 tests is time consuming, inconvenient for the patient, and provides marginally improved positive and negative predictive values that may not be clinically relevant. However, a combination of 2 of these methods is sometimes more helpful for identifying foods likely to induce allergic reactions.

Quality of evidence: Low

Contribution of expert opinion: Significant

Food Elimination Diets

Guideline 10: The EP suggests that elimination of 1 or a few specific foods from the diet may be useful in the diagnosis of FA, especially in identifying foods responsible for some non-IgE-mediated food-induced allergic disorders, such as food protein-induced enterocolitis syndrome (FPIES), allergic proctocolitis (AP), and Heiner syndrome, and some mixed IgE- and non-IgE-mediated food-induced allergic disorders, such as EoE.

Rationale: The use of an elimination diet in combination with a convincing history may be sufficient to diagnose FA in several food-induced allergic disorders, including FPIES, AP, and Heiner syndrome, and some mixed IgE- and non-IgE-mediated food induced allergic disorders, such as EoE.

Balance of benefits and harms: In several non-IgE-mediated FA disorders and EoE, a suggestive medical history plus the elimination of the suspected food resulting in the resolution of symptoms provides evidence for the diagnosis of FA. In these situations, there are no known laboratory tests that are diagnostic of the causative food, and the oral food challenge, while a potentially useful diagnostic test, may provoke significant morbidity. Thus, many health care professionals base the initial diagnosis on history and clearing of symptoms while on the elimination diet, and reserve the oral food challenge for evaluating the eventual resolution of the disorder (i.e., development of tolerance).

Quality of evidence: Low

Contribution of expert opinion: Significant

Oral Food Challenges

Guideline 11: The EP recommends using oral food challenges for diagnosing FA. The double-blind, placebo-controlled food challenge (DBPCFC) is the gold standard. However, a single-blind or an open-food challenge may be considered diagnostic under certain circumstances: if either of these challenges elicits no symptoms (i.e., the challenge is negative), then FA can be ruled out; but when either challenge elicits objective symptoms (i.e., the challenge is positive) and those objective symptoms correlate with medical history and are supported by laboratory tests, then a diagnosis of FA is supported.

Rationale: DBPCFC is the most specific test for diagnosing FA. However, due to the expense and inconvenience of DBPCFCs, single-blind and open-food challenges may be used in the clinical setting.

Balance of benefits and harms: The DBPCFC markedly reduces potential bias of patients and supervising health care professionals that may interfere with the appropriate interpretation of oral food challenges, and corresponds most closely to the natural ingestion of food. Other diagnostic tests lack specificity and may lead to the unnecessary exclusion of foods from patients' diets. However, the DBPCFC is time consuming, expensive, and, like any form of oral food challenge, subjects the patient to potential severe allergic reactions. Single-blind and open-food challenges are frequently used to screen patients for FA. When negative, they may be considered diagnostic in ruling out FA, and when positive (i.e., when "immediate" objective allergic symptoms are elicited), they may be considered diagnostic in patients who have a supportive medical history and laboratory data.

Quality of evidence: High

Contribution of expert opinion: Moderate

Note: Because of the inherent risk, an oral food challenge must be conducted at a medical facility that has onsite medical supervision and appropriate medicines and devices on hand.

Nonstandardized and Unproven Procedures

Guideline 12: The EP recommends not using any of the following nonstandardized tests for the routine evaluation of IgE-mediated FA:

  • Basophil histamine release/activation
  • Lymphocyte stimulation
  • Facial thermography
  • Gastric juice analysis
  • Endoscopic allergen provocation
  • Hair analysis
  • Applied kinesiology
  • Provocation neutralization
  • Allergen-specific immunoglobulin G4 (IgG4)
  • Cytotoxicity assays
  • Electrodermal test (Vega)
  • Mediator release assay (Lifestyle, Eating and Performance [LEAP] diet)

Rationale: There is a lack of evidence demonstrating that any of these nonstandardized tests has any value in the diagnosis of FA. However, although basophil histamine release/activation is not a routine diagnostic test for IgE-mediated FA, it is commonly used as a research tool.

Balance of benefits and harms: The utility of these tests has not been validated for the diagnosis of FA and may result in false positive or false negative diagnoses, leading to unnecessary dietary restrictions or delaying the appropriate diagnostic workup, respectively.

Quality of evidence: Low

Contribution of expert opinion: Significant

Diagnosis of Non-IgE-Mediated Immunologic Adverse Reactions to Food

Eosinophilic Gastrointestinal Diseases

Guideline 13: The EP suggests that SPTs, sIgE tests, and APTs may be considered to help identify foods that are associated with EoE, but these tests alone are not sufficient to make the diagnosis of FA. The role of these tests in the diagnosis of other eosinophilic GI diseases (EGIDs) has not been established.

Rationale: SPTs, sIgE tests, and APTs alone are insufficient to establish a causal role for FA in EoE, but they may be useful in identifying foods that should be investigated further with other diagnostic tests, such as dietary elimination, oral food challenge, and endoscopy and esophageal biopsy.

Balance of benefits and harms: Some studies suggest that SPTs, sIgE tests, and APTs may be of value in identifying foods that cause symptoms of EoE. However, the utility of these tests has not been validated for the diagnosis of FA in EoE or other EGIDs and may result in false positive or false negative diagnoses.

Quality of evidence: Low

Contribution of expert opinion: Significant

Food Protein-Induced Enterocolitis Syndrome

Guideline 14: The EP recommends using the medical history and oral food challenge to establish a diagnosis of food protein-induced enterocolitis syndrome (FPIES). However, when history indicates that infants or children have experienced hypotensive episodes or multiple reactions to the same food, a diagnosis may be based on a convincing history and absence of symptoms when the causative food is eliminated from the diet.

Rationale: FPIES is diagnosed based on a supportive medical history, resolution of symptoms with the elimination of the causative food, and, in many cases, provocation of symptoms following an open or single-blind oral food challenge.

Balance of benefits and harms: There are no laboratory studies with demonstrated specificity and sensitivity to diagnose FPIES, so an oral food challenge is necessary to establish the diagnosis. Although the oral food challenge may induce significant symptoms, there are no alternative methods with adequate predictability to diagnose FPIES. However, when the history is very compelling (for example, 2 or more reactions with classic symptoms to the same food in a 6-month period and elimination of symptoms when the causative food is removed from the diet), an oral food challenge may not be necessary to make the diagnosis. Because this disorder often lasts only a few years, however, subsequent oral food challenge is warranted to determine when FPIES has resolved and the food elimination diet can be terminated.

Quality of evidence: High

Contribution of expert opinion: Moderate

Food Protein-Induced Allergic Proctocolitis

Guideline 15: The EP recommends using the medical history, resolution of symptoms when the causative food is eliminated from the diet, and recurrence of symptoms following an oral food challenge to diagnose AP.

Rationale: The evidence supports the conclusion that food protein-induced AP can be diagnosed based on a supportive medical history, resolution of symptoms with the elimination of the causative food, and recurrence of symptoms following an oral food challenge.

Balance of benefits and harms: Because there are no laboratory studies with sufficient specificity and sensitivity to diagnose food protein-induced AP, an oral food challenge is necessary to establish the diagnosis. Although the food challenge may induce blood in the stools, symptoms of AP are generally benign, and there are no alternative methods with adequate predictability to diagnose AP. In cases with a classic history of AP, a normal physical examination and resolution of symptoms following elimination of the causative food leads many investigators to believe that an oral food challenge is not required to establish the diagnosis. Since this disorder often lasts only 1 to 2 years, repeated challenges are warranted to determine when food elimination diets can be terminated.

Quality of evidence: Moderate

Contribution of expert opinion: Significant

Allergic Contact Dermatitis

Guideline 16: The EP recommends using the medical history, including the absence of symptoms while the causative food is avoided, and positive patch tests to diagnose allergic contact dermatitis (ACD).

Rationale: There are a limited number of well-controlled studies demonstrating the utility of these methods in diagnosing ACD. However, the concept that patch testing can be useful in establishing the diagnosis of ACD is based on both the underlying immunologic mechanism involved in the disease and observations from general medical practice.

Balance of benefits and harms: Traditionally, patch testing has been used to support history in diagnosing ACD. Although there are insufficient well-controlled studies to demonstrate the benefits of these methods in diagnosing ACD, the concept of patch testing largely fits with the immunopathogenic mechanism involved. The harm of avoiding contact with the food identified by this method appears minimal.

Quality of evidence: Moderate

Contribution of expert opinion: Significant

Systemic Contact Dermatitis

Guideline 17: The EP suggests using the medical history, including the resolution of symptoms while the causative food is avoided, and positive patch tests to establish the diagnosis of systemic contact dermatitis.

Rationale: Insufficient well-controlled studies exist to demonstrate the utility of these methods in diagnosing systemic contact dermatitis.

Balance of benefits and harms: Traditionally, patch testing has been used to support a suggestive history in diagnosing this rare condition. Although there are few well-controlled studies to demonstrate the benefits of these methods in diagnosing systemic contact dermatitis, those that exist support the utility of these methods. The harm of eliminating a small number of foods on this basis appears minimal.

Quality of evidence: Low

Contribution of expert opinion: Significant

Diagnosis of IgE-Mediated Contact Urticaria

Guideline 18: The EP suggests using the medical history, including the absence of symptoms while the causative food is avoided, positive sIgE tests or SPTs, and positive immediate epicutaneous skin tests (for example, positive immediate responses to APTs), to establish the diagnosis of food-induced IgE-mediated contact urticaria.

Rationale: There are a limited number of well-controlled studies demonstrating the utility of these methods in diagnosing IgE mediated contact urticaria, but traditionally these methods have been used and found to correlate with clinical symptoms.

Balance of benefits and harms: Although there are few well controlled studies to demonstrate the benefits of these methods in diagnosing IgE-mediated contact urticaria, test results appear to correlate with clinical symptoms. The potential harm of avoiding contact with foods provoking contact urticaria appears to be minimal.

Quality of evidence: Low

Contribution of expert opinion: Significant

Management of Nonacute Allergic Reactions and Prevention of Food Allergy

Management of Individuals with Food Allergy

Dietary Avoidance of Specific Allergens in IgE-Mediated Food Allergy

Guideline 19: The EP recommends that individuals with documented IgE-mediated FA should avoid ingesting their specific allergen or allergens.

Rationale: The EP recognizes that allergen avoidance is a strategy that is unproven in randomized controlled trials (RCTs). However, allergen avoidance is currently the safest strategy for managing FA.

Balance of benefits and harms: For individuals with FA, ingesting food allergens can cause allergic reactions ranging in severity from mild to life-threatening. Carefully planned allergen-free diets can provide sufficient nutrients to maintain a healthy and active life. In addition, there is no evidence that strict food avoidance (compared with less strict avoidance) has any effect on the rate of natural remission to a specific food allergen.

Quality of evidence: Low

Contribution of expert opinion: Significant

Dietary Avoidance of Specific Allergens in Non-IgE-Mediated Food Allergy

Guideline 20: The EP recommends that individuals with documented non-IgE-mediated FA should avoid ingesting their specific allergen or allergens.

Rationale: The literature cannot readily be divided on the basis of IgE-mediated and non-IgE-mediated reactions. In general, the management of non-IgE-mediated FA is similar to that of IgE-mediated FA, in that the medical history, the age of the individual, and the specific food allergen are all-important considerations in developing the management plan. Although there are relatively few high-quality studies regarding treatment for non-IgE mediated FA, the bulk of the evidence suggests that food avoidance is the best management plan.

Balance of benefits and harms: For individuals with FA, ingesting trigger foods can cause allergic reactions and serious illness. Carefully planned allergen-free diets can provide sufficient nutrients to maintain a healthy and active life. In addition, there is no evidence that strict food avoidance (compared with less strict avoidance) has any effect on the rate of natural remission to a specific food allergen.

Quality of evidence: Low

Contribution of expert opinion: Significant

Effects of Dietary Avoidance on Associated and Comorbid Conditions, Such as Atopic Dermatitis, Asthma, and Eosinophilic Esophagitis

Guideline 21: In individuals with documented or proven FA who also have 1 or more of the following—AD, asthma, or EoE—the EP recommends avoidance of their specific allergen or allergens.

Rationale: Only limited study data exist on this issue. In appropriately diagnosed individuals with FA, food allergen avoidance may reduce the severity of AD or EoE. Current evidence is not available to indicate whether food allergen avoidance will alter the course of AD, asthma, or EoE.

Balance of benefits and harms: This approach is not an additional burden for individuals already practicing food avoidance to manage FA.

Quality of evidence: Low

Contribution of expert opinion: Significant

Guideline 22: In individuals without documented or proven FA, the EP does not recommend avoiding potentially allergenic foods as a means of managing AD, asthma, or EoE.

Rationale: No conclusive evidence exists to suggest that avoiding food allergens reduces the severity of AD, asthma, or EoE in individuals who are not sensitized and have not demonstrated specific clinical reactivity to foods.

Balance of benefits and harms: Unnecessary food avoidance could place individuals at risk for nutritional deficiencies and growth deficits. There is no known benefit to avoiding potentially allergenic foods (such as [cow's] milk, egg, peanut, tree nuts, wheat, soy, fish, and crustacean shellfish).

Quality of evidence: Moderate

Contribution of expert opinion: Moderate

Food Avoidance and Nutritional Status

Guideline 23: The EP recommends nutritional counseling and regular growth monitoring for all children with FA.

Rationale: Although few studies have evaluated whether food allergen avoidance results in nutritional deficiency, the EP acknowledges that obtaining adequate nutrition is a concern in this population.

Balance of benefits and harms: Avoidance of specific allergens can limit the availability of nutritious food choices. Nutrition counseling can help patients plan and consume an allergen-free yet nutritionally adequate diet.

Quality of evidence: Low

Contribution of expert opinion: Significant

Food Labeling in Food Allergy Management

Guideline 24: The EP suggests that individuals with FA and their caregivers receive education and training on how to interpret ingredient lists on food labels and how to recognize labeling of the food allergens used as ingredients in foods. The EP also suggests that products with precautionary labeling, such as "this product may contain trace amounts of allergen," be avoided.

Rationale: Although current requirements under the Food Allergen Labeling and Consumer Protection Act (FALCPA) require food labels to disclose the presence of any of the 8 major food allergens when used as ingredients, the law does not address precautionary labeling. Precautionary labeling is voluntary and is used at the manufacturer's discretion. Ingredient labeling is not completely effective in preventing unintentional exposure to allergens.

Balance of benefits and harms: Ingredient lists on food packages can help consumers identify the contents of products, but may be difficult to interpret. FALCPA provides for the use of plain-language labels for ingredients that are, or that contain, major food allergens. Difficult-to-interpret voluntary precautionary labeling statements place individuals at risk for unintentional exposure to allergens.

Quality of evidence: Low

Contribution of expert opinion: Significant

When to Re-evaluate Patients with Food Allergy

Guideline 25: The EP suggests follow-up testing for individuals with FA depending on the specific food to which the individual is allergic. Whether testing is done annually or at other intervals depends on the food in question, the age of the child, and the intervening medical history.

Rationale: Insufficient evidence exists to make a specific recommendation as to the timing for re-evaluating individuals for FA.

Balance of benefits and harms: It is recognized that children will likely outgrow allergies to certain foods, such as milk, egg, soy, and wheat, and be less likely to outgrow allergies to other foods, such as peanut, tree nuts, fish, and crustacean shellfish. Results of follow-up testing can guide decision making regarding whether and when it is safe to introduce or re-introduce allergenic food into the diet.

Quality of evidence: Moderate

Contribution of expert opinion: Significant

Pharmacologic Intervention for the Prevention of Food-Induced Allergic Reactions

IgE-Mediated Reactions

Guideline 26: There are no medications currently recommended by the EP to prevent IgE-mediated food-induced allergic reactions from occurring in an individual with existing FA.

Rationale: The current evidence does not support the use of pharmacologic therapy for IgE-mediated reactions to food.

Balance of benefits and harms: Pharmacologic agents have the potential to prevent or lessen the severity of food-induced allergic reactions by altering the immune response, but these agents may display significant side effects and predispose individuals to an increased risk for infection. Only limited safety and cost effectiveness data are currently available.

Quality of evidence: Moderate

Contribution of expert opinion: Significant

Non-IgE-Mediated Reactions

Guideline 27: There are no medications currently recommended by the EP to prevent non-IgE-mediated food-induced allergic reactions from occurring in an individual with existing FA.

Rationale: The current evidence does not support the use of pharmacologic therapy to prevent non-IgE-mediated FA reactions.

Balance of benefits and harms: The use of swallowed corticosteroids has the potential to lessen the severity of or prevent future food-induced allergic reactions, but these medications may cause significant side effects and predispose individuals to an increased risk for infection. Nevertheless, swallowed corticosteroids have been shown to be beneficial in the treatment of EoE.

Quality of evidence: Moderate

Contribution of expert opinion: Significant

Immunotherapy for Food Allergy Management

Allergen-Specific Immunotherapy

Guideline 28: The EP does not recommend using allergen-specific immunotherapy to treat IgE-mediated FA.

Rationale: Allergen-specific immunotherapy improves clinical symptoms of FA while on treatment. However, it is currently difficult to draw conclusions on the safety of such an approach and whether clinical tolerance (i.e., improvement in clinical symptoms that persists even after allergen-specific immunotherapy is discontinued) will develop with long-term treatment.

Balance of benefits and harms: Allergen-specific immunotherapy can improve clinical symptoms of FA for some patients. However, additional safety and efficacy data are needed before such treatment can be recommended. Because of the risk of severe reactions, the approach should only be used in highly controlled settings.

Quality of evidence: Low

Contribution of expert opinion: Significant

Immunotherapy with Cross-Reactive Allergens

Guideline 29: The EP does not recommend immunotherapy with cross-reactive allergens for treating IgE-mediated FA.

Rationale: Although some evidence exists to suggest that specific immunotherapy with cross-reactive allergens is beneficial in treating FA, additional safety and efficacy data are needed before such treatment can be recommended.

Balance of benefits and harms: It has been hypothesized that immunotherapy with cross-reactive antigens could benefit patients with FA, yet the safety of this approach has been evaluated in a highly controlled setting in only 1 study to date. Replication of these findings with additional safety and efficacy data in clinical practice settings is needed.

Quality of evidence: Low

Contribution of expert opinion: Significant

Quality-of-Life Issues Associated with Food Allergy

Guideline 30: The EP recommends that patients with FA and their caregivers be provided with information on food allergen avoidance and emergency management that is age and culturally appropriate.

Rationale: Food-allergen avoidance and the risk of severe allergic reactions can have substantial daily consequences for patients and their caregivers.

Balance of benefits and harms: Patients with FA and their caregivers (especially mothers) can experience anxiety and diminished quality of life because of the risk of anaphylaxis and the burden of selecting or preparing allergen-free foods. Concerns may change as patients with FA mature. Knowledge and skills related to management of FA may improve patient and caregiver self-efficacy, quality of life, and successful allergen avoidance.

Quality of evidence: Low

Contribution of expert opinion: Significant

Vaccinations in Patients with Egg Allergy

In summary: Patients who have generated IgE antibodies to an allergen are at risk for anaphylaxis with systemic exposure to that allergen. Thus, patients who have IgE-mediated egg allergy are at risk for anaphylaxis if injected with vaccines containing egg protein. More detailed information on specific egg-containing vaccines (measles, mumps, rubella [MMR], measles mumps, rubella, varicella [MMRV], influenza, yellow fever, and rabies) is provided below and in sections 5.1.11.1 to 5.1.11.4 of the original guideline document.

Measles, Mumps, Rubella, and Varicella Vaccine

Guideline 31: The EP recognizes the varying consensus recommendations of the different organizations on this particular vaccine and recommends that children with egg allergy, even those with a history of severe reactions, receive vaccines for MMR and for MMRV. The safety of this practice has been recognized by the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) and is noted in the approved product prescribing information for these vaccines.

Rationale: MMR and MMRV vaccines are safe for children with egg allergy, even for those with a history of severe reactions.

Balance of benefits and harms: Vaccinations can prevent severe disease, and in most states proof of MMR vaccination is required for school entry. Varicella vaccine also is required in most states. The measles component of the vaccine is produced in chicken-embryo fibroblasts, which may be of concern to parents of children with egg allergy. However, MMR and MMRV vaccines are safe to administer to these children because the egg protein content of these vaccines is very low. Severe allergic adverse events attributable to varicella vaccination are extremely rare, and serious allergic reactions could be due to non-egg vaccine components, including gelatin.

Quality of evidence: Moderate

Contribution of expert opinion: Significant

Influenza Vaccine

In summary: The EP concludes that insufficient evidence exists to recommend administering influenza vaccine, either inactivated or live-attenuated, to patients with a history of severe reactions to egg proteins. Severe reactions include a history of hives, angioedema, allergic asthma, or systemic anaphylaxis to egg proteins (or chicken proteins). Less severe or local manifestations of allergy to egg or feathers are not contraindications. However, the EP notes that egg allergy is relatively common among the very patients who would highly benefit from influenza vaccination. Such patients include children and young adults (from 6 months to 18 years old for seasonal influenza and from 6 months to 24 years old for H1N1 influenza) and all patients with asthma. It should be noted that live-attenuated vaccine is not licensed for use in patients with asthma.

Yellow Fever Vaccine

In summary: The EP recognizes the current guidelines from the different organizations and recommends against administering yellow fever vaccine to patients with a history of hives, angioedema, allergic asthma, or systemic anaphylaxis to egg proteins, unless an allergy evaluation and testing with the vaccine is done first. This approach has been recognized by ACIP and AAP and is noted in the approved product prescribing information for this vaccine.

Rabies Vaccines

In summary: The EP recognizes the current guidelines from the different organizations and recommends against administering rabies vaccines to patients with a history of hives, angioedema, allergic asthma, or systemic anaphylaxis to egg proteins, unless an allergy evaluation and testing with the vaccine is done first. This approach has been recognized by ACIP and AAP and is noted in the approved product prescribing information for these vaccines.

Management of Individuals at Risk for Food Allergy

Nonfood Allergen Avoidance in At-risk Patients

Guideline 32: The EP suggests that patients at risk for developing FA do not limit exposure to potential nonfood allergens (for example, dust mites, pollen, or pet dander). Patients at risk for developing FA are defined as those with a biological parent or sibling with existing, or history of, allergic rhinitis, asthma, AD, or FA.

Rationale: Insufficient evidence exists to suggest that avoidance of allergens that are not food allergens has any effect on the natural history of FA.

Balance of benefits and harms: It has been hypothesized that exposure to nonfood allergens could increase the likelihood of developing an FA in patients at risk for atopic disease, but there are insufficient data to support this hypothesis.

Quality of evidence: Low

Contribution of expert opinion: Significant

Dietary Avoidance of Foods with Cross Reactivities in At-risk Patients

Guideline 33: The EP suggests that patients at risk for developing FA do not need to limit exposure to foods that may be cross-reactive with the 8 major food allergens in the United States (milk, egg, peanut, tree nuts, soy, wheat, fish, and crustacean shellfish).

Rationale: Insufficient evidence exists to determine whether eating foods that cross-react with the major allergenic foods will cause symptoms.

Balance of benefits and harms: It has been hypothesized that exposure to possible cross-reactive foods could result in an allergic response. However, unnecessary food avoidance can result in inadequate nutrient intake and growth deficits.

Quality of evidence: Low

Contribution of expert opinion: Significant

Testing of Allergenic Foods in Patients at High Risk Prior to Introduction

In summary: The EP concludes that insufficient evidence exists to recommend routine FA testing prior to the introduction of highly allergenic foods (such as milk, egg, and peanut) in children who are at high risk of reacting to the introduction of such foods. The definition of children at high risk, in this specific situation, is children with pre-existing severe allergic disease and/or a family history of FA. Nevertheless, there may be some value in FA evaluations that include an oral food challenge for a select group of patients with certain risk factors, such as having a sibling with peanut allergy or evidence of another underlying FA (for example, testing for tree nut allergy in a child with peanut allergy). It is possible that an FA evaluation prior to introduction of a food could potentially prevent allergic reactions. However, widespread SPTs and sIgE tests are not recommended because of their poor predictive value. These tests would lead to many clinically irrelevant results and unnecessary dietary restrictions, especially if unconfirmed by oral food challenges. Overall, the risk-to benefit ratio of FA evaluation should be considered on an individual basis, especially for the highly allergenic foods in high-risk young children.

Guideline 34: The EP suggests that the general population of children not be tested for FA to highly allergenic foods prior to their introduction into the diet. The general population of children does not have pre-existing severe allergic disease and also does not have a family history of FA.

Rationale: Insufficient evidence exists to suggest whether, or which, foods should be tested prior to introduction.

Balance of benefits and harms: Testing prior to introduction could potentially prevent allergic reactions, but there is currently no practical consensus on which (if any) foods should be tested.

Quality of evidence: Low

Contribution of expert opinion: Significant

Testing in Infants and Children with Persistent Atopic Dermatitis

Guideline 35: The EP suggests that children less than 5 years old with moderate to severe AD be considered for FA evaluation for milk, egg, peanut, wheat, and soy, if at least 1 of the following conditions is met:

  • The child has persistent AD in spite of optimized management and topical therapy.
  • The child has a reliable history of an immediate reaction after ingestion of a specific food.

Rationale: Insufficient evidence exists to determine the appropriate age to test for response to foods known to commonly cause IgE-mediated FA in infants or young children with AD or other risk factors. In spite of the lack of evidence, the opinion of the EP is that if a child is less than 5 years old and has persistent AD, there is benefit to finding out whether the child is allergic to a food.

Balance of benefits and harms: Early diagnosis can lead to better management of FA and reduce the risk of exposure to food antigens. However, testing is time-consuming and costly for patients and their families. In addition, severely restrictive diets may be harmful. Care should be taken to ensure these children are clinically allergic to a food prior to removing it completely from their diet.

Quality of evidence: Low

Contribution of expert opinion: Significant

Prevention of Food Allergy

Maternal Diet during Pregnancy and Lactation

Guideline 36: The EP does not recommend restricting maternal diet during pregnancy or lactation as a strategy for preventing the development or clinical course of FA.

Rationale: Insufficient evidence exists that maternal diet during pregnancy or lactation affects the development or clinical course of FA.

Balance of benefits and harms: Restricting exposure to food antigens either during pregnancy or through breast milk has been hypothesized as a means of preventing the development of FA, but it has not been shown conclusively to prevent FA. Adequate nutritional status during pregnancy and lactation is essential for optimal infant health, growth, and development.

Quality of evidence: Low

Contribution of expert opinion: Significant

Breast-feeding

Guideline 37: The EP recommends that all infants be exclusively breast-fed until 4 to 6 months of age, unless breastfeeding is contraindicated for medical reasons.

Rationale: There is not strong evidence that breast-feeding has a protective role in preventing atopic disease. However, because of other benefits of breast-feeding, it is recommended that all infants, including those with a family history of atopic disease, be exclusively breast-fed until 4 to 6 months of age, unless breastfeeding is contraindicated for medical reasons.

Balance of benefits and harms: Whether exclusive breastfeeding has a beneficial role in preventing atopic disease is unclear, but there are no potential harms associated with exclusive breast-feeding until 4 to 6 months of age.

Quality of evidence: Low

Contribution of expert opinion: Significant

Special Diets in Infants and Young Children

Soy Infant Formula versus Cow's Milk Infant Formula

Guideline 38: The EP does not recommend using soy infant formula instead of cow's milk infant formula as a strategy for preventing the development of FA or modifying its clinical course in at-risk infants ("at-risk" is defined in Guideline 32 above).

Rationale: The literature reports little difference between soy infant formula and cow's milk infant formula for the prevention of FA in at-risk infants.

Balance of benefits and harms: There appears to be neither long-term harm nor significant benefit in using soy infant formula.

Quality of evidence: Moderate

Contribution of expert opinion: Minimal

Hydrolyzed Infant Formulas versus Cow's Milk Infant Formula or Breast-feeding

Guideline 39: The EP suggests that the use of hydrolyzed infant formulas, as opposed to cow's milk formula, may be considered as a strategy for preventing the development of FA in at-risk infants who are not exclusively breast-fed ("at-risk" is defined in Guideline 32 above). Cost and availability of extensively hydrolyzed infant formulas may be weighed as prohibitive factors.

Rationale: Only a limited number of studies exist to indicate that extensively or partially hydrolyzed infant formulas reduce the development of cow's milk allergy (CMA) in at-risk infants.

Balance of benefits and harms: The preventive effects of hydrolyzed infant formulas on allergy in infants and children vary considerably from study to study. Evidence from a small number of large-population studies shows that feeding hydrolyzed infant formulas, as compared with cow's milk infant formula, to at-risk infants may reduce, albeit to a small extent, allergy in infants and children and CMA in infants. None of the studies show reduction in allergy to foods other than cow's milk. Practical and cost considerations of extensively hydrolyzed infant formulas may limit their use to infants who are at risk and not being exclusively breast-fed. There is no evidence to suggest exclusive feeding with a hydrolyzed infant formula is more likely to prevent atopic disease than exclusive breast-feeding. The influence of duration of use on the effect of hydrolyzed infant formula on the development of allergy is not known.

Quality of evidence: Moderate

Contribution of expert opinion: Moderate

Timing of Introduction of Allergenic Foods to Infants

Guideline 40: The EP suggests that the introduction of solid foods should not be delayed beyond 4 to 6 months of age. Potentially allergenic foods may be introduced at this time as well.

Rationale: Insufficient evidence exists for delaying introduction of solid foods, including potentially allergenic foods, beyond 4 to 6 months of age, even in infants at risk (as defined in Guideline 32 above) of developing allergic disease.

Balance of benefits and harms: Restricting exposure to food antigens during infancy has been hypothesized as a means of preventing development of FA. However, restricting developmentally appropriate solid food variety beyond age 6 months can lead to inadequate nutrient intake, growth deficits, and feeding problems.

Quality of evidence: Low

Contribution of expert opinion: Significant

Diagnosis and Management of Food-induced Anaphylaxis and Other Acute Allergic Reactions to Foods

Diagnosis of Acute, Life-threatening, Food-induced Allergic Reactions

Guideline 41: The EP recommends that the health care professional considering a diagnosis of food-induced anaphylaxis should understand:

  • The signs and symptoms characteristic of anaphylaxis
  • The timing of symptoms in association with food ingestion/exposure
  • Comorbid conditions, such as asthma, that may affect treatment and outcome
  • The limited utility of laboratory parameters in the acute care setting

Rationale: The evidence and expert opinion support prompt recognition and diagnosis of food-induced anaphylaxis.

Balance of benefits and harms: Prompt recognition and diagnosis of food-induced anaphylaxis are essential and necessary to ensure appropriate health outcomes and to prevent progression to life-threatening reactions. Potential harm, including the possibility of death, exists if the diagnosis is delayed or not recognized.

Quality of evidence: Low

Contribution of expert opinion: Significant

Treatment of Acute, Life-threatening, Food-induced Allergic Reactions

First-Line and Adjuvant Treatment for Food-Induced Anaphylaxis

Guideline 42: The EP recommends that treatment for food-induced anaphylaxis should focus on the following:

  • Prompt and rapid treatment after onset of symptoms (see Table below) for a summary of treatment in an outpatient or hospital setting)
  • Intramuscular (IM) epinephrine as first-line therapy
  • Other treatments, which are adjunctive to epinephrine dosing

Rationale: Evidence supports the implementation of rapid response and treatment for food-induced anaphylaxis and the use of IM epinephrine as first-line therapy.

Balance of benefits and harms: The benefits of appropriate treatment for anaphylaxis begin with IM epinephrine injection. Benefits of epinephrine treatment far outweigh the risks of unnecessary dosing. Delays in instituting therapy with epinephrine are associated with risks of death and morbidity.

Quality of evidence: Moderate

Contribution of expert opinion: Significant

Table: Summary of the Pharmacologic Management of Anaphylaxis

Note: These treatments often occur concomitantly, and are not meant to be sequential, with the exception of epinephrine as first-line treatment.

In the Outpatient Setting
  • First-line treatment:
    • Epinephrine, IM; auto-injector or 1:1,000 solution
      • Weight 10 to 25 kg: 0.15 mg epinephrine autoinjector, IM (anterior-lateral thigh)
      • Weight >25 kg: 0.3 mg epinephrine autoinjector, IM (anterior-lateral thigh)
      • Epinephrine (1:1,000 solution) (IM), 0.01 mg/kg per dose; maximum dose, 0.5 mg per dose (anterior-lateral thigh)
    • Epinephrine doses may need to be repeated every 5-15 minutes
  • Adjunctive treatment:
    • Bronchodilator (β2-agonist): albuterol
      • Metered-dose inhaler (MDI) (child: 4-8 puffs; adult: 8 puffs) or
      • Nebulized solution (child: 1.5 ml; adult: 3 ml) every 20 minutes or continuously as needed
    • H1 antihistamine: diphenhydramine
      • 1 to 2 mg/kg per dose
      • Maximum dose, 50 mg IV or oral (oral liquid is more readily absorbed than tablets)
      • Alternative dosing may be with a less-sedating second generation antihistamine 
    • Supplemental oxygen therapy
    • IV fluids in large volumes if patient presents with orthostasis, hypotension, or incomplete response to IM epinephrine
    • Place the patient in recumbent position if tolerated, with the lower extremities elevated
In the Hospital-based Setting
  • First-line treatment:
    • Epinephrine IM as above, consider continuous epinephrine infusion for persistent hypotension (ideally with continuous non-invasive monitoring of blood pressure and heart rate); alternatives are endotracheal or intra-osseous epinephrine
  • Adjunctive treatment:
    • Bronchodilator (β2-agonist): albuterol
      • MDI (child: 4-8 puffs; adult: 8 puffs) or
      • Nebulized solution (child: 1.5 ml; adult: 3 ml) every 20 minutes or continuously as needed
    • H1 antihistamine: diphenhydramine
      • 1 to 2 mg/kg per dose
      • Maximum dose, 50 mg IV or oral (oral liquid is more readily absorbed than tablets)
      • Alternative dosing may be with a less-sedating second generation antihistamine
    • H2 antihistamine: ranitidine
      • 1 to 2 mg/kg per dose
      • Maximum dose, 75 to 150 mg oral and IV
    • Corticosteroids
      • Prednisone at 1 mg/kg with a maximum dose of 60 to 80 mg oral or
      • Methylprednisolone at 1 mg/kg with a maximum dose of 60 to 80 mg IV
    • Vasopressors (other than epinephrine) for refractory hypotension, titrate to effect
    • Glucagon for refractory hypotension, titrate to effect
      • Child: 20-30 µg/kg
      • Adult: 1-5 mg
      • Dose may be repeated or followed by infusion of 5-15 µg/min
    • Atropine for bradycardia, titrate to effect
    • Supplemental oxygen therapy
    • IV fluids in large volumes if patients present with orthostasis, hypotension, or incomplete response to IM epinephrine
    • Place the patient in recumbent position if tolerated, with the lower extremities elevated
Therapy for the Patient at Discharge
  • First-line treatment:
    • Epinephrine auto-injector prescription (2 doses) and instructions
    • Education on avoidance of allergen
    • Follow-up with primary care physician
    • Consider referral to an allergist
  • Adjunctive treatment:
    • H1 antihistamine: diphenhydramine every 6 hours for 2-3 days; alternative dosing with a non-sedating second generation antihistamine
    • H2 antihistamine: ranitidine twice daily for 2-3 days
    • Corticosteroid: prednisone daily for 2-3 days

Modified from Liberman DB, Teach SJ. Management of anaphylaxis in children. Pediatr Emerg Care 2008 Dec;24(12):861-6.

In summary: The use of antihistamines is the most common reason reported for not using epinephrine and may place a patient at significantly increased risk for progression toward a life-threatening reaction.

Management of Food-induced Anaphylaxis

Guideline 43: The EP recommends that the management of food-induced anaphylaxis should focus on the following:

  • Dosing with IM epinephrine followed by transfer to an emergency facility for observation and possible further treatment
  • Observation for 4 to 6 hours or longer based on severity of the reaction
  • Education for patient and family on:
    • Allergen avoidance
    • Early recognition of signs and symptoms of anaphylaxis
    • Anaphylaxis emergency action plan implementation
    • Appropriate IM epinephrine administration
    • Medical identification jewelry or an anaphylaxis wallet card
  • Epinephrine auto-injector prescription and training provided at the time of discharge
  • Continuation of adjunctive treatment after patient discharge:
    • H1 antihistamine: diphenhydramine every 6 hours for 2-3 days; alternative dosing with a non-sedating second generation antihistamine
    • H2 antihistamine: ranitidine twice daily for 2-3 days
    • Corticosteroid: prednisone daily for 2-3 days
  • Follow-up appointment with primary health care professional (after the food-induced anaphylactic reaction), with consideration for additional follow-up with a clinical specialist such as an allergist/immunologist.

Rationale: Despite the lack of evidence, the EP recommends close monitoring, scheduled follow-up, and patient education for effective management following anaphylaxis.

Balance of benefits and harms: The benefits of appropriate management following food-induced anaphylaxis should serve to further protect the patient through long-term follow-up care and education, with the benefit of preventing subsequent events. The potential harm is minimal if appropriate education is employed.

Quality of evidence: Low

Contribution of expert opinion: Significant

Definitions:

Quality of Evidence

Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, RAND provided a grade of high, moderate, or low as a measure of the quality of evidence, according to the following criteria:

  • High—Further research is very unlikely to have an impact on the quality of the body of evidence, and therefore the confidence in the recommendation is high and unlikely to change.
  • Moderate—Further research is likely to have an impact on the quality of the body of evidence and may change the recommendation.
  • Low—Further research is very likely to have an important impact on the body of evidence and is likely to change the recommendation.

Defining the Strength of Each Clinical Guideline

The EP has used the verb "recommends" or "suggests" in each clinical guideline. These words convey the strength of the guideline, defined as follows:

  • Recommend is used when the EP strongly recommended for or against a particular course of action.
  • Suggest is used when the EP weakly recommended for or against a particular course of action.
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each summary statement (see "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits
  • Improved quality of care in the prevention, diagnosis, and management of food allergies
  • Reduced morbidity and mortality related to food allergy or misdiagnosis of food allergy

Refer to the "Balance of benefits and harms" for each guideline in the "Major Recommendations" field for specific benefits of individual recommendations.

Potential Harms
  • Because unnecessary food avoidance affects quality of life and nutrition, there is possible harm in over-diagnosing food allergy (FA).
  • There is a greater risk of systemic adverse allergic reactions from intradermal tests compared with skin prick tests.
  • Unnecessary food avoidance could place individuals at risk for nutritional deficiencies and growth deficits.
  • In therapeutic doses and by any route, epinephrine frequently causes mild transient adverse effects in individuals of all ages. These include anxiety, fear, restlessness, headache, dizziness, palpitations, pallor, and tremor. Rarely, epinephrine may lead to ventricular arrhythmias, angina, myocardial infarction, pulmonary edema, sudden sharp increase in blood pressure, and intracranial hemorrhage. There are subgroups of patients who might theoretically be at higher risk for adverse effects during epinephrine therapy. Some level of decision making regarding the risk-to-benefit ratio may be warranted, and especially for patients:
    • Who have cardiovascular disease and are reluctant to receive epinephrine due to fear of adverse cardiac effects. These patients should be made aware that myocardial ischemia and dysrhythmias can occur in untreated anaphylaxis.
    • Receiving monoamine oxidase inhibitors (which block epinephrine metabolism) or tricyclic antidepressants (which prolong epinephrine duration of action).
    • Receiving stimulant medications (for example, amphetamines or methylphenidate used in the treatment of attention-deficit-hyperactivity disorder) or abusing cocaine.
    • With certain pre-existing conditions, such as recent intracranial surgery, aortic aneurysm, uncontrolled hyperthyroidism, or hypertension.
  • Rapid administration of glucagon can induce vomiting.
  • Sedation and cognitive and psychomotor impairment are recognized side effects of the first-generation H1 antihistamines, and these may contribute to decreased awareness of anaphylaxis symptoms.

Refer to the "Balance of benefits and harms" for each guideline in the "Major Recommendations" field for specific harms or risks of individual recommendations.

Contraindications

Contraindications
  • Influenza vaccine is contraindicated in individuals with egg allergy.
  • Yellow fever vaccine is generally contraindicated in individuals with egg allergy, but desensitization protocols may be followed to administer vaccine if necessary.

Qualifying Statements

Qualifying Statements

The Guidelines are intended to assist health care professionals in making appropriate decisions about patient care in the United States. The recommendations are not fixed protocols that must be followed. Health care professionals should take these Guidelines into account when exercising their clinical judgment. However, this guidance does not override their responsibility to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient, guardian, or caregiver. Clinical judgment on the management of individual patients remains paramount. Health care professionals, patients, and their families need to develop individual treatment plans that are tailored to the specific needs and circumstances of the patient. This document is intended as a resource to guide clinical practice and develop educational materials for patients, their families, and the public. It is not an official regulatory document of any government agency.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Chart Documentation/Checklists/Forms
Patient Resources
Quick Reference Guides/Physician Guides
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Timeliness

Identifying Information and Availability

Bibliographic Source(s)
Boyce JA, Assa'ad A, Burks AW, Jones SM, Sampson HA, Wood RA, Plaut M, Cooper SF, Fenton MJ, NIAID-Sponsored Expert Panel, Arshad SH, Beck LA, Byrd-Bredbenner C, Camargo CA Jr, Eichenfield L, Furuta GT, Hanifin JM, Jones C, Kraft M, Levy BD, Lieberman P, Luccioli S, McCall KM, Schneider LC, Simon RA, Simons FE, Teach SJ, Yawn BP, Schwaninger JM. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol. 2010 Dec;126(6 Suppl):S1-58. [347 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 Dec
Guideline Developer(s)
National Institute of Allergy and Infectious Diseases - Federal Government Agency [U.S.]
Source(s) of Funding

Publication of this article was supported by the Food Allergy Initiative.

Guideline Committee

Expert Panel and Coordinating Committee

Composition of Group That Authored the Guideline

Primary Authors: Joshua A. Boyce, MD, Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Department of Medicine Harvard Medical School, Boston, Mass; Amal Assa'ad, MD, Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio; A. Wesley Burks, MD, Division of Allergy and Immunology, Department of Pediatrics, Duke University Medical Center, Durham, NC; Stacie M. Jones, MD, Division of Allergy and Immunology, Department of Pediatrics, University of Arkansas for Medical Sciences, Arkansas Children's Hospital, Little Rock, Ark; Hugh A. Sampson, MD, Elliot and Roslyn Jaffe Food Allergy Institute, Division of Allergy and Immunology, Department of Pediatrics, Mount Sinai School of Medicine, New York, NY; Robert A. Wood, MD, Division of Allergy and Immunology, Department of Pediatrics, The Johns Hopkins University School of Medicine, Baltimore, Md; Marshall Plaut, MD, Division of Allergy, Immunology, and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md; Susan F. Cooper, MSc, Division of Allergy, Immunology, and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md; Matthew J. Fenton, PhD, Division of Allergy, Immunology, and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md

NIAID-Sponsored Expert Panel Authors: S. Hasan Arshad, MBBS, MRCP, DM, FRCP, School of Medicine, University of Southampton, Southampton, UK, The David Hide Asthma and Allergy Research Centre, St Mary's Hospital, Newport, Isle of Wight, UK, Southampton University Hospital NHS Trust, Southampton, UK; Sami L. Bahna, MD, DrPH, Department of Pediatrics, Section of Allergy and Immunology, Louisiana State University Health Sciences Center, Shreveport, La; Lisa A. Beck, MD, Department of Dermatology, University of Rochester Medical Center, Rochester, NY; Carol Byrd-Bredbenner, PhD, RD, FADA, Department of Nutritional Sciences, Rutgers University, New Brunswick, NJ; Carlos A. Camargo Jr, MD, DrPH, Department of Emergency Medicine, Division of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Mass; Lawrence Eichenfield, MD, Division of Pediatric and Adolescent Dermatology, Rady Children's Hospital, San Diego, Calif, Departments of Pediatrics and Medicine, University of California, San Diego, San Diego, Calif; Glenn T. Furuta, MD, Section of Pediatric Gastroenterology, Hepatology, and Nutrition, Digestive Health Institute, Children's Hospital Denver, Aurora, Colo, Department of Pediatrics, National Jewish Health, Denver, Colo, Department of Pediatrics, University of Colorado Denver School of Medicine, Aurora, Colo; Jon M. Hanifin, MD, Department of Dermatology, Oregon Health and Science University, Portland, Ore; Carol Jones, RN, AE-C, Asthma Educator and Consultant, Allergy and Asthma Network Mothers of Asthmatics, McLean, Va; Monica Kraft, MD, Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Duke University Medical Center, Durham, NC; Bruce D. Levy, MD, Partners Asthma Center, Pulmonary and Critical Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass; Phil Lieberman, MD, Division of Allergy and Immunology, Department of Medicine, University of Tennessee College of Medicine, Memphis, Tenn; Stefano Luccioli, MD, Office of Food Additive Safety, US Food and Drug Administration, College Park, Md; Kathleen M. McCall, BSN, RN, Children's Hospital of Orange County, Orange, Calif; Lynda C. Schneider, MD, Division of Immunology, Children's Hospital Boston, Boston, Mass; Ronald A. Simon, MD, Division of Allergy, Asthma and Immunology, Scripps Clinic, San Diego, Calif; F. Estelle R. Simons, MD, Departments of Pediatrics and Child Health and Immunology, Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada; Stephen J. Teach, MD, MPH, Division of Emergency Medicine, Children's National Medical Center, Washington, DC; Barbara P. Yawn, MD, MPH, MSc, Department of Research, Olmsted Medical Center, Rochester, Minn; Department of Family and Community Health, University of Minnesota School of Medicine, Minneapolis, Minn

Contributing Author: Julie M. Schwaninger, MSc, Division of Allergy, Immunology, and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md

Financial Disclosures/Conflicts of Interest

J. A. Boyce has served on the Advisory Board of GlaxoSmithKline. He has served as a consultant and/or speaker for Altana, GlaxoSmithKline, and Merck. He has received funding/grant support from the National Institutes of Health.

A. Assa'ad holds, or is listed as an inventor on, US patent application #10/566903, entitled "Genetic markers of food allergy." She has served as a consultant for GlaxoSmithKline and as a speaker for the American College of Allergy, Asthma, and Immunology; the North East Allergy Society; the Virginia Allergy Society; the New England Allergy Society; and the American Academy of Pediatrics. Dr Assa'ad has received funding/grant support from GlaxoSmithKline.

A.W. Burks holds, or is listed as an inventor on, multiple US patents related to food allergy. He owns stock in Allertein and MastCell, Inc, and is a minority stockholder in Dannon Co Probiotics. He has served as a consultant for ActoGeniX NV, McNeil Nutritionals, Mead Johnson, and Novartis. He has served on the speaker’s bureau for EpiPen/Dey, LP, and has served on the data monitoring committee for Genentech. He has served on an expert panel for Nutricia. Dr Burks has received funding/grant support from the Food Allergy and Anaphylaxis Network, Gerber, Mead Johnson, and the National Institutes of Health.

S. M. Jones has served as a speaker and grant reviewer and has served on the medical advisory committee for the Food Allergy and Anaphylaxis Network. She has received funding/grant support from Dyax Corp, the Food Allergy and Anaphylaxis Network, Mead Johnson, the National Peanut Board, and the National Institutes of Health.

H. A. Sampson holds, or is listed as an inventor on, multiple US patents related to food allergy. He owns stock in Allertein Therapeutics. He is the immediate past president of the American Academy of Allergy, Asthma, and Immunology. He has served as a consultant for Allertein Therapeutics; the American Academy of Allergy, Asthma, and Immunology; the Food Allergy Initiative; and Schering Plough. He has received funding/grant support for research projects from the Food Allergy Initiative, the National Institutes of Health (Division of Receipt and Referral, National Institute of Allergy and Infectious Diseases, National Center for Complementary and Alternative Medicine), and Phadia AB. He is a co owner of Herbal Spring, LLC.

R. A. Wood has served as a speaker/advisory board member for GlaxoSmithKline, Merck, and Dey. He has received funding/grant support from Genentech and the National Institutes of Health (National Institute of Allergy and Infectious Diseases).

S. H. Arshad has received funding/grant support from the National Institutes of Health and the National Institute of Health Research, UK.

S. L. Bahna has received funding/grant support from Genentech.

L. A. Beck has received funding/grant support from the American Academy of Allergy, Asthma, and Immunology; the National Eczema Association; and the National Institutes of Health.

C. Byrd-Bredbenner owns stock in Johnson & Johnson. She has received funding/grant support from the US Department of Agriculture, the Canned Food Alliance, and the New Jersey Department of Health and Senior Services.

C. A. Camargo Jr has consulted for Dey and Novartis. He has received funding/grant support from a variety of government agencies and not-for-profit research foundations, as well as Dey and Novartis.

L. Eichenfield has received funding/grant support from a variety of not-for-profit foundations, as well as Astellas, Ferndale, Johnson & Johnson, Novartis, Sinclair, Stiefel, and Therapeutics Inc.

G. T. Furuta has served as a consultant and/or speaker to Ception Therapeutics and TAP. He has received funding/grant support from the American Gastrointestinal Association and the National Institutes of Health.

J. M. Hanifin has served as served as a consultant for ALZA, Anesiva, Inc, Barrier Therapeutics, Inc, Milliken & Company, Nordic Biotech, Novartis Pharmaceuticals Corporation, Shionogi USA, Taisho Pharmaceutical R&D, Inc, Teikoku Pharma USA, Inc, UCB, York Pharma, ZARS, Inc, and ZymoGenetics. He has served as an investigator or received research funding from ALZA, Astellas Pharma US, Inc, Asubio Pharmaceuticals, Inc, Centocor, Inc, Corgentech, Novartis, Nucryst Pharmaceuticals, Seattle Genetics, and Shionogi USA.

M. Kraft has served as a consultant and/or speaker for AstraZeneca, Genentech, GlaxoSmithKline, Merck, Novartis, and Sepracor. She has received funding/grant support from Genentech, GlaxoSmithKline, the National Institutes of Health and Novartis.

B. D. Levy holds, or is listed as an inventor on, US patent applications #20080064746 entitled "Lipoxins and aspirin-triggered lipoxins and their stable analogs in the treatment of asthma and inflammatory airway diseases" and #20080096961 entitled "Use of docosatrienes, resolvins and their stable analogs in the treatment of airway diseases and asthma." He owns stock in Resolvyx Pharmaceuticals. He has served as a consultant for Bayer Healthcare and Resolvyx Pharmaceuticals. Dr Levy has received funding/grant support from the National Institutes of Health.

P. Lieberman has served as a consultant and/or speaker to Dey Laboratories, Novartis, Schering-Plough, AstraZeneca, Merck, TEVA, Pfizer, MEDA, Alcon, Genentech, Intelliject, and the Food Allergy and Anaphylaxis Network. He is past president of the American Academy of Allergy, Asthma, and Immunology.

L. C. Schneider has served as a consultant/clinical advisor for the Food Allergy Initiative. She has received funding/grant support from a variety of not-for-profit research foundations, as well as Novartis and the National Institutes of Health.

R. A. Simon has served as a speaker for Dey Laboratories, Genentech, GlaxoSmithKline, Merck, Novartis, and the US Food and Drug Administration.

F. E. R. Simons holds a patent on "Fast-disintegrating epinephrine tablets for sublingual administration." She is a past-president of the American Academy of Allergy, Asthma, and Immunology and of the Canadian Society of Allergy and Clinical Immunology. She is a member of the advisory boards of Dey, Intelliject, and ALK-Abello. She has received funding/grant support from AllerGen; the Canadian Allergy, Asthma and Immunology Foundation/Anaphylaxis Canada; and the Canadian Institutes of Health Research.

S. J. Teach has served as a speaker for AstraZeneca. He has received funding/grant support from the AstraZeneca Foundation, Aventis, the Child Health Center Board, the CNMC Research Advisory Council, the National Association of Chain Drug Stores Foundation, the National Institutes of Health (National Institute of Allergy and Infectious Diseases; National Heart, Lung, and Blood Institute), Novartis/Genentech, the Robert Wood Johnson Foundation, the US Centers for Disease Control and Prevention, the US Public Health Service, and the Washington, DC, Department of Health.

The other authors have declared that they have no conflict of interest.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the National Institute of Allergy and Infectious Diseases (NIAID) Web site External Web Site Policy.

Availability of Companion Documents

The following are available:

  • Guidelines for the diagnosis and management of food allergy in the United States. Summary of the NIAID-sponsored expert panel report. Bethesda (MD): National Institute of Allergy and Infectious Diseases (NIAID); 2010 Dec. 29 p. Electronic copies: Available from the NIAID Web site External Web Site Policy.
  • Prevalence, natural history, diagnosis, and treatment of food allergy. A systematic review of the evidence. 415 p. Electronic copies: Available from the RAND Corporation Web site External Web Site Policy.

In addition, Appendix E of the original guideline document External Web Site Policy contains a sample anaphylaxis emergency action plan.

Patient Resources

The following is available:

  • What's in it for patients? Guidelines for the Diagnosis and Management of Food Allergy in the United States. Bethesda (MD): National Institute of Allergy and Infectious Diseases (NIAID). Available from the NIAID Web site External Web Site Policy.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI Institute on February 17, 2011. The information was verified by the guideline developer on April 27, 2011.

Copyright Statement

No copyright restrictions apply.

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