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Potential Hypersensitivity due to the Food or Food Additive Content of Medicinal Products in Spain


Document Written by the Drug Allergy Committee of the Spanish Society of Allergology and Clinical Immunology (Sociedad Española de Alergología e Inmunología Clínica, SEAIC)
MT Audicana Berasategui,1 MJ Barasona Villarejo,2 M Corominas Sánchez,3 M De Barrio Fernández,4 MC García Avilés,5 JC García Robaina,6 G Gastaminza Lasarte,7 JJ Laguna Martínez,8 T Lobera Labairu,9 M López San Martín,10 J Martín Lázaro,11 E Moreno Rodilla,12 N Ortega Rodríguez,13 MJ Torres Jaén14

1Hospital Santiago Apóstol, Vitoria, Spain
2Hospital Universitario Reina Sofía, Córdoba, Spain
3Hospital Universitari de Bellvitge, L’Hospitalet del Llobregat, Barcelona, Spain
4Hospital General Universitario Gregorio Marañon, Madrid, Spain
5Hospital de Torrevieja, Alicante, Spain
6Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain
7Clínica Universidad de Navarra, Pamplona, Spain
8Hospital Central de la Cruz Roja, Madrid, Spain
9Hospital San Pedro, Logroño, Spain
10Hospital Universitario Puerta de Hierro, Majadahonda, Spain
11Hospital Arquitecto Marcide, La Coruña, Spain
12Hospital Universitario, Salamanca, Spain
13Hospital General de Gran Canaria Dr. Negrín, Las Palmas, Spain
14Hospital Civil, Málaga, Spain

J Investig Allergol Clin Immunol 2011; Vol. 21(7): 496-506



The Drug Allergy Committee of the Spanish Society of Allergology and Clinical Immunology reviewed the allergenic potential of several substances of food origin that are found in the composition of some drugs. Despite recent legislation on labeling, many labels do not clearly state whether the drug contains raw material (active ingredients, excipient, or other manufacturing intermediate) with an origin in any of the substances in the list of the 14 groups of food allergens that are subject to mandatory declaration. The objective of legislation is that the drug package, the Summary of Product Characteristics, and the patient information leafl et clearly state the food content in order to improve the safety of allergic patients.
Therefore, any food or allergen derivative that must be declared should be clearly stated on the drug label. Of all the evaluated products, egg and milk derivatives are the most frequently discussed in literature reviews. The natural or synthetic origin of potentially allergenic substances such as lysozyme, casein, lactose, albumin, phosphatide, and aromatic essences should be clearly stated.
Providing this information has 2 clear advantages. First, allergic reactions to drugs in patients with food allergy could be avoided (if the substances have a natural origin). Second, prescription would improve by not restricting drugs containing synthetic substances (which do not usually induce allergic reactions).

Key words
: Food allergy. Drug allergy. Additive. Egg. Milk.