Reações adversas dos adjuvantes farmacêuticos presentes em medicamentos para uso pediátrico / Adverse reactions of pharmaceutical adjuvants present in drugs for pediatric use

RESUMO

Excipientes são substâncias auxiliares que compõem as formas farmacêuticas e, normalmente, são consideradas inertes. No entanto, mesmo em baixas concentrações, esses constituintes podem desencadear efeitos indesejáveis que podem comprometer a terapêutica medicamentosa. Neste sentido, o presente estudo teve como objetivo identificar possíveis excipientes indutores de reação adversa contidos em medicamentos para uso oral pediátrico. Para realização desta pesquisa, foi adotada a técnica de análise de documentos a partir de bulas de medicamentos de formulações líquidas pediátricas constantes no Dicionário de Especialidades Farmacêuticas. Acebrofilina, dimeticona, dipirona e paracetamol foram os medicamentos selecionados para identificação dos excipientes. Em 40 apresentações farmacêuticas pesquisadas, foram identificados 23 excipientes dos quais seis foram considerados como possíveis causadores de reações adversas. Das formulações analisadas, 97,5% continham excipientes de risco que foram relacionados da seguinte forma: 24 continham metilparabeno, 20 propilparabeno, 11 sorbitol, nove benzoato de sódio, cinco tartrazina e dois bissulfito de sódio. Esses excipientes podem ocasionar urticária, asma brônquica, transtornos gastrointestinais, náuseas, vômitos, entre outros efeitos. Portanto, os excipientes têm um papel importante no aparecimento dos efeitos adversos, especialmente na Pediatria.

ABSTRACT

Excipients are auxiliary substances involved in the composition of pharmaceuticals. Although excipients are defined as inert substances, this definition has been proved inadequate. Most excipients are used in low concentrations, although they can lead to untoward effects. In clinical practice, such reactions are wrongly attributed to the active drug, leaving out of account the fact that excipients are considered responsible for adverse effects. The objective of the present study was identify the presence of excipients which can possibly induce adverse reactions, present in drugs marketed for pediatric use in Brazil. This qualitative and exploratory study used the technique of document analysis to assess drug labels of liquid formulations listed in the Pharmaceutical Dictionary and directed at the pediatric population. Four pharmaceuticals were selected: acebrophylline, dimethicone, dipyrone and paracetamol. The excipients cited in the literature as possible inducers of adverse reactions were selected for this study from their identification in the pharmaceutical formulations studied. In 40 presentations assessed, 23 excipients were identified as possible inducers of adverse reactions. The presence of a risk excipient was identified in 97.5% of the formulations assessed, according to the following distribution: 24 contained methyl paraben, 20 propyl paraben, 11 sorbitol, 9 sodium benzoate, 5 tartrazine and 2 sodium bisulfite. Pediatric patients are exposed to adverse effects such as urticaria, bronchial asthma, gastrointestinal upset, nausea, vomiting and others, due to the presence of the excipients methylparaben and propylparaben, sodium benzoate, sulfites in general, tartrazine yellow dye and sorbitol, in most liquid formulations assessed, most of them marketed as over-the-counter drugs.