Abstract In pediatrics, drug therapy is commonly performed through adaptations of the dosage forms to adult use, increasing the risk of adverse drug reactions. In this context, studies assessing the severity and avoidability of the adverse reactions in children, especially those caused by antimicrobials, are still scarce. This work aimed to investigate suspected antimicrobial adverse reactions (ATM-ADRs) in pediatric patients admitted to a public hospital in northeastern Brazil, focusing on causality and avoidability analysis. A cohort study was carried out over a period of six months in a 64-bed pediatric unit. The incidence of suspected adverse reactions caused by antimicrobials was 14.65%. Most reactions were rated as probable (89.13%), with moderate severity (84.78%) and possibly avoidable (45.65%). The analysis indicated that the use of a larger number of medications (p<0.0001) and longer hospital stay (p=0.004) were related to the occurrence of ATM-ADR. Our findings demonstrated that almost half of the suspected reactions could be prevented and that the antimicrobial’s clinical management is relevant in this context. Besides, increasingly accurate adverse reaction classification instruments are essential. These results can support the development of therapeutic guidelines addressed to a safe and effective pharmacotherapy in the pediatric area.

Objetivo: Estudar os sinais e sintomas apresentados nas reações aos hemocomponentes registradas no Hospital Geral Dr. Waldemar de Alcântara (HGWA). Método: O estudo mostra a análise de sinais e sintomas das notificações de reações e avaliação dos dados obtidos a partir das fichas de notificação de hemovigilância de um hospital público secundário e acreditado nível 2, segundo a ONA. Resultados: A média de idade dos pacientes que apresentaram reações foi de 48,31 +-27,2 anos, variando de 2 meses a 94 anos, sendo 52,5% do sexo feminino. Foram analisados os sinais e sintomas apresentados pelos pacientes internados no HGWA que foram acometidos por reações transfusionais, no período de janeiro a dezembro de 2010. De um total de 4899 bolsas de hemocomponentes transfundidas 48,6% corresponderam a concentrados de hemácias, 34,4% plasma fresco congelado, 13,3% concentrados de plaquetas e 3,8% crioprecipitados. Dentre as indicações, as justificativas para uso foram 65,5% anemia, 12,2% hemorragia, 12,2% tempos de coagulação alterados e 9,8% plaquetopenia. Um total de 70,7% das reações foram provocadas por concentrado de hemácias, 17,1% por plasma fresco congelado e 12,2% por concentrado de plaquetas. As reações imediatas representaram 92,7% do total. Os principais sintomas apresentados nas reações foram febre (55,6%), dispnéia e urticária (8,9% cada). Conclusão: O concentrado de hemácias foi o hemocomponente mais transfundido. O setor que mais consumiu hemocomponentes foi UTI. Quanto às indicações para a hemotransfusão destacou-se a anemia, seguida da hemorragia. Os principais sinais e sintomas encontrados foram os de fácil observação como febre, dispnéia e urticária.

Objective: To study the signs and symptoms presented in blood products reactions registered in the Hospital Geral Dr. Waldemar de Alcântara (HGWA). Method: The study shows the analysis of signs and symptoms of reaction reports and evaluation of data obtained from the notification forms hemovigilance in a secondary public hospital and accredited level 2, according to ONA. Results: The mean age of patients who had reactions was 48.31 ±27.2 years, ranging from 2 months to 94 years, 52.5% were female. Were analyzed the signs and symptoms presented by patients admitted to HGWA that were affected by transfusion reactions, in the period January to December 2010. From a total of 4899 bags of transfused blood products accounted for 48.6% of packed red blood cells, 34.4% fresh frozen plasma, platelet concentrates 13.3% and 3.8% cryoprecipitate. Among the indications, the reasons for use were 65.5% anemia, 12.2% hemorrhage, 12.2% clotting times changed and 9.8% thrombocytopenia. A total of 70.7% of the reactions were caused by red blood cells, 17.1% for fresh frozen plasma and 12.2% for platelet concentrate. Immediate reactions accounted for 92.7% of the total. The main symptoms in the reactions were fever (55.6%), dyspnea, urticaria (8.9% each). Conclusion: The packed red blood cells was the blood product more transfused. The IcU was the sector where these products are most consumed. regarding indications for blood transfusion stood out anemia, followed by hemorrhage. The main signs and symptoms found were easily observed as fever, dyspnea and urticaria.