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Revista Brasileira de Ciências Farmacêuticas

Print version ISSN 1516-9332


SILVA, Antonio Vinicios Alves da; FONSECA, Said Gonçalves da Cruz; ARRAIS, Paulo Sérgio Dourado  and  FRANCELINO, Eudiana Vale. The presence of pharmaceutical excipients as possible cause of adverse drug reactions (ADR) - situation in Brazil. Rev. Bras. Cienc. Farm. [online]. 2008, vol.44, n.3, pp.397-405. ISSN 1516-9332.

Pharmaceutical excipients can be responsible for many ADR. The objectives of this study were to identify the presence of possible excipients as cause of ADR in drugs commercialized in Brazil. Twelve medicines with high indices of sales in Brazil, were selected to analysis. The bibliographic research about the Pharmaceutical Preparations (PP) was carried from August to September/04. The sources of information used were Pharmaceutical Specialties Dictionary, web sites and customer services from the manufacturers and technical files of the National Agency of Sanitary Vigilance. The excipients were detected as a whole and also the compounds that may cause adverse reactions and its risks to the health. They were identified 35 PP. Of these, 26 were classified as Over-The-Counter medicines (OTC) (71.4%) and 15 of paediatric use (42.8%). Between the excipients identified (n=100), 9 were possible causes of ADR: metylparaben, propylparaben, yellow dye tartrazine, sodium bissulfit, sodium benzoate, lactose, benzalkonium chloride, sorbitol and benzílic alcohol, being identified in 7 use in paediatric (19.0%) and 12 of OTC (32.4%). The results shows the need of more attention from the health professionals, the patient and the development of evaluation by the pharmacovigilance systems, of the presence of excipients as possible inductors of ADR.

Keywords : Drugs [adverse reactions]; Pharmaceutical excipients; Pharmacovigilance; Pharmaceutical preservatives.

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