Incidence of adverse drug reaction associated with tigecycline

Abstract

T is a bactericidal antibiotic accredited by the National Sanitary Surveillance Agency, in Brazil in 2006. In the United States, it was released in 2005 for the treatment of complicated skin infections, soft tissues and intra-abdominal. It is known that Fase IV studies, which information is obtained as from real conditions, are of great relevance in pharmacovigilance scope. So, it was objectified to analyse the incidence of adverse drug reactions (ADRs) in hospitalized patients submitted to tigecycline therapy. It is a cohort study. The sample was compounded by sixteen adult patients who were hospitalized during June 2009 to June 2011. The gathering of data was retrospective using medical records. The ADRs causalities were determined by Naranjo Algorithm. The project was approved by the Research Ethics Committee with human beings from NTOI (n° 0047.0.305.000-11). The patients average age was 62 years old, 62% from the female sex, the hospitalization average was 199 days and in 68% of the patients the use of tigecycline was for the treatment of Acinetobacter infections. The incidence of ADRs associated with tigecycline was 37% and were related to the gastrointestinal disorders, skin disorders, renal and urinary disorders and increase of pancreatic enzyme. It is concluded that in the ADRs notification, specially drugs that are in the market for less than 5 years, the accurate description of the event is essential, even if through a weak evidence study.