2001, Number 4
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ABSTRACTIn Mexico, the generic drug market is growing. Regarding topical corticosteroids, there are several preparations on the local market but their clinical efficacy has not been assessed in relation with the original brand name. Using as a model the fluocinolone acetonide cream, the purpose of this study was to evaluate the antiinflammatory effect of different preparations. A double-blind, vehicle-control essay was conducted causing irritation on five sites of the volar aspect of the forearm in twenty healthy volunteers using 10% aqueous sodium lauryl sulfate. On the same part of the forearm, the formulations tested were applied for a period of 4 days with visual score irritation readings at days 2 and 4. The analysis of the results showed that although one of the generic drugs is 80% less expensive than the brand-name medication, the clinical response was not as good as the other preparations. This deserves consideration, as newer and more potent generic corticosteroids will be available on the Mexican market.
Norma Oficial Mexicana de Emergencia NOM-EM-003-SSAI-1998, medicamentos genéricos intercambiables. Criterios y requisitos de las pruebas para demostrar la intercambiabilidad y requisitos a que deben sujetarse los terceros autorizados. Diario Oficial de la Federación, DXXXX 18, 25 sept. México. 1998. p. 75-94.
Brasch J, Becker D, Effendy I. Reproducibility of irritant patch test reactions to sodium lauryl sulfate in a double-blind placebo-controlled randomized study using clinical scoring. Results from a study group of the German Contact Dermatitis Research Group (Deutsche Kontaktallergie-Gruppe, DKG). Contact Dermatitis 1999;41:150-5.