Fórmulas infantiles hipoalergénicas

AMERICAN ACADEMY OF PEDIATRICS
Committee on Nutrition

Hypoallergenic Infant Formulas
ABSTRACT. The American Academy of Pediatrics is committed to breastfeeding as the ideal source of nutrition for infants. For those infants who are formula-fed, either as a supplement to breastfeeding or exclusively during their infancy, it is common practice for pediatricians to change the formula whensymptoms of intolerance occur. Decisions about when the formula should be changed and which formula should be used vary significantly, however, among pediatric practitioners. This statement clarifies some of these issues as they relate to protein hypersensitivity (protein allergy), one of the causes of adverse reactions to feeding during infancy.
ABBREVIATION. IgE, immunoglobulin E.

ymptoms of foodprotein allergy include those commonly associated with immunoglobulin E (IgE)-associated reactions, such as angioedema, urticaria, wheezing, rhinitis, vomiting, eczema, and anaphylaxis.1 Non–IgE-associated, immunologically mediated conditions have also been associated with the ingestion of cow’s milk, soy, and other dietary proteins in infant feedings. These disorders include pulmonaryhemosiderosis,2 malabsorption with villous atrophy,3 eosinophilic proctocolitis,4 enterocolitis,5 and esophagitis.6 Finally, some infants may experience extreme irritability or colic as the only symptom of food protein allergy.7 The prevalence in infancy of milk protein allergy is low—2% to 3%.8 –10 Thus, the use of hypoallergenic-labeled infant formulas, which cost as much as 3 times more than standardformulas, should be limited to infants with well-defined clinical indications. Adverse reactions to cow’s milk associated with other conditions such as phenylketonuria and lactose intolerance may also be alleviated by the use of alternative formulas, although not necessarily those intended to treat infants with protein allergy.
FORMULA DEVELOPMENT AND LABELING

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Before new potentialhypoallergenic formulas are tested in trials using human infants, comprehensive preclinical testing must be conducted to examine for toxicity and suitability to maintain a positive nitrogen balance and to attempt to predict whether infants allergic to cow’s milk will react adversely to them. This testing should include efforts to determine the molecular weight profile of residual pepThe recommendations inthis statement do not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate. PEDIATRICS (ISSN 0031 4005). Copyright © 2000 by the American Academy of Pediatrics.

tides, the amount of immunologically recognizable material present, and the ability of the product to sensitize or provokereactions in animal models of allergenicity.11–14 To establish the risk of hypersensitivity in infants, carefully conducted preclinical studies must be performed that demonstrate a formula may be hypoallergenic. The formula needs to be tested in infants with hypersensitivity to cow’s milk or cow’s milkbased formula and the findings verified by properly conducted elimination-challenge tests.15 These testsshould, at a minimum, ensure with 95% confidence that 90% of infants with documented cow’s milk allergy will not react with defined symptoms to the formula under double-blind, placebo-controlled conditions.16 Such formulas can be labeled hypoallergenic. If the formula being tested is not derived from cow’s milk proteins, the formula must also be evaluated in infants or children with documentedallergy to the protein from which the formula was derived. It is also recommended that after a successful double-blind challenge, the clinical testing should include an open challenge using an objective scoring system to document allergic symptoms during a period of 7 days.16 This is particularly important to detect late-onset reactions to the formula.17 Any formula with residual peptides may...