Safety of ingestion of yellow tartrazine by double-blind placebo controlled challenge in 26 atopic adults.
BACKGROUND
Yellow dye tartrazine is a potential cause of exacerbations of asthma, allergic rhinitis and urticaria in atopic patients. The Brazilian Sanitary Surveillance Agency (ANVISA) published a consultation about the possibility of issuing a label warning addressing these potential effects of food and drugs containing tartrazine. The present study aims to evaluate tartrazine dye safety in atopic subjects suffering from allergic rhinitis, asthma, urticaria or sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs).


METHODS
Atopic patients with allergic rhinitis, asthma, urticaria or pseudo-allergic reactions to non-steroidal anti-inflammatory drugs were studied (n=26). The gold standard, double-blind placebo controlled, crossed-over challenge was used


RESULTS
There were no statistical differences between placebo and drug in cutaneous, respiratory or cardiovascular aspects.


CONCLUSIONS
In a group of atopic subjects with allergic rhinitis, asthma, urticaria or pseudo-allergic reactions to non-steroidal anti-inflammatory drugs, the administration of 35 mg of the tartrazine dye did not precipitate any kind of significant cutaneous, respiratory or cardiovascular reactions when compared to placebo.
Pestana
S
S
Medical Sciences Post Graduation Course, Universidade Federal Fluminense, Niteroi, 24030-215, Rio de Janeiro, Brasil .
Moreira
M
M
Olej
B
B
D000293:Adolescent; D000328:Adult; D000368:Aged; D055963:Asthma, Aspirin-Induced / Q000209:etiology* / Q000503:physiopathology; D004311:Double-Blind Method; D004435:Eating; D005260:Female; D005505:Food Coloring Agents / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012221:Rhinitis, Allergic, Perennial / Q000209:etiology* / Q000503:physiopathology; D006255:Rhinitis, Allergic, Seasonal / Q000209:etiology* / Q000503:physiopathology; D013645:Tartrazine / Q000008:administration & dosage / Q000009:adverse effects*
D005505:Food Coloring Agents; D010919:Placebos; D013645:Tartrazine