Clinical Pharmacology & Biopharmaceutics
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Daptomycin is a bactericidal antibiotic accredited by the National Sanitary Surveillance Agency, in Brazil in 2009. In the United
States, it was released in 2003 for the treatment of skin infections and soft tissues caused by gram-positive cocci. 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 daptomycin
therapy. It is a cohort study. The sample was compounded by nine adult patients who were hospitalized during June 2010 to June
2012. 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? 0045.0.305.000-11). The patients
average age was 57 years old, 66% from the female sex, the hospitalization average was 37 days and in 89% of the patients the use of
daptomycin was for the treatment of MRSA infections. The incidence of ADRs associated with daptomycin was 55% and the ADRs
identified were related to the respiratory, digestive, hematopoietic, central nervous and immune systems. It is concluded that in
the ADRs notification, specially drugs that are in the market for less than 5 years, the precisive description of the event is essential,
even if through a weak evidence study.
Tathiana Silva de Souza Martins pursued Ph.D. in the Adult Health Nursing Program at The Sao Paulo University and Masters in Nursing by the
Fluminense Federal University. Assistant professor of the Care Nursing Master?s Degree at Fluminense Federal University. Risk manager at The
National Traumatology and Orthopedics Institute, responsible for the pharmacovigilance.
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