title: Adverse drug reactions to antiretroviral therapy: prospective study in children in sikasso (mali).
abstract: OBJECTIVE
  Adverse events during antiretroviral treatment are frequent and various. Their diagnosis incurs some various difficulties according to the geographic context. Our aim was to describe the frequency, nature, and preventability of adverse drug reactions (ADRs) due to antiretroviral treatment in Malian outpatient children.
  
  
  METHODS
  The study was a 6-month (June 1 to November 30, 2010) prospective, observational study of 92 children admitted to a pediatric hospital in Sikasso, Mali. The patients were treated with a generic drug and/or drug combinations. Prior to treatment initiation, demographic characteristics, clinical history, and biologic parameters, including CD4 cell counts, were collected for each patient. The World Health Organization's adverse drug reactions classification was used to characterize the side effects. Adverse effects and toxicities were graded 1, 2, and 3. Analysis of data was performed using SPSS Version 17.0 software.
  
  
  RESULTS
  Ninety-two human immunodeficiency virus-infected children met the criteria of inclusion. After 24 weeks of treatment, we observed that 14.1% of children had at least one side effect during our study. Side effects were many and varied, with the most frequent being cutaneous rash, nausea, vomiting, and diarrhea (38.5%, 23.1%, 15.4%, and 15.4%, respectively). Side effects were grade 1 in most cases. One case of grade 2 and one case of grade 3 were observed with rash. We observed one case of grade 3 side effects during our study. The treatment regimen was changed in 15.2% of cases, including one case because of side effects.
  
  
  CONCLUSIONS
  ADRs are not rare in Mali, particularly in children. These ADRs have an impact on quality of life for patients. We recommend a pharmacovigilance system for sustainable management of side effects in patients infected with human immunodeficiency virus in Mali.
authors: Faculty of Medicine, Pharmacy, and Odonto-stomatology, University of Bamako, Bamako, Mali,  ; HIV/TB Research and Training Center, Bamako, Mali.
authors: Aboubacar A
authors: AA
authors: Oumar
authors: Korotoumou
authors: K
authors: Diallo
authors: Jean P
authors: JP
authors: Dembélé
authors: Lassana
authors: L
authors: Samaké
authors: Issa
authors: I
authors: Sidibé
authors: Boubacar
authors: B
authors: Togo
authors: Mariam
authors: M
authors: Sylla
authors: Anatole
authors: A
authors: Tounkara
authors: Sounkalo
authors: S
authors: Dao
authors: Paul M
authors: PM
authors: Tulkens
keywords: Mali; adverse drug reactions; antiretroviral therapy; children