Potential hypersensitivity due to the food or food additive content of medicinal products in Spain.
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 leaflet 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).
Hospital Santiago Apóstol, Vitoria, Spain. mariateresa.audicanaberasategi@osakidetza.net
M T
MT
Audicana Berasategui
M J
MJ
Barasona Villarejo
M
M
Corominas Sánchez
M
M
De Barrio Fernández
M C
MC
García Avilés
J C
JC
García Robaina
G
G
Gastaminza Lasarte
J J
JJ
Laguna Martínez
T
T
Lobera Labairu
M
M
López San Martín
J
J
Martín Lázaro
E
E
Moreno Rodilla
N
N
Ortega Rodríguez
M J
MJ
Torres Jaén
D004342:Drug Hypersensitivity / Q000209:etiology*; D005503:Food Additives / Q000009:adverse effects*; D005512:Food Hypersensitivity / Q000209:etiology*; D005944:Glucosamine / Q000009:adverse effects; D006801:Humans; D007785:Lactose / Q000009:adverse effects; D009113:Muramidase / Q000009:adverse effects; D010047:Ovalbumin / Q000009:adverse effects; D015742:Propofol / Q000009:adverse effects; D013030:Spain
D005503:Food Additives; D010047:Ovalbumin; D009113:Muramidase; D007785:Lactose; D005944:Glucosamine; D015742:Propofol