title: Adverse drug reactions associated with antiretroviral treatment among adult Ethiopian patients in a tertiary hospital.
abstract: BACKGROUND
  Adverse drug reactions (ADRs) are frequently encountered among patients taking Antiretroviral Treatment (ART). The aim of this study was to describe the type and frequency of ADRs among adult Ethiopians on ART.
  
  
  OBJECTIVE
  to describe the type and frequency of short term adverse drug reactions among adult Ethiopian patients on ART at Tikur Anbessa teaching Hospital in Addis Ababa, Ethiopia.
  
  
  METHODS
  From October 2008 to December 2009, 228 HIV positive patients were enrolled to a tertiary teaching hospital in Addis Ababa. Patients were closely monitored for ADRs for a median observation period of 18 weeks (79 total person-years of observation). Time-dependent occurrence of clinical adverse effects and abnormal laboratory values as defined by the AIDS Clinical Trial Group were analyzed (41).
  
  
  RESULTS
  A total of 392 ARV drug related ADRs occurred Mild GI disturbances (36.8%) and headache (35.9%) were the most frequently reported symptoms. Thirty (7.7%) of the ADRs were severe requiring change or interruption of therapy (19 hematological and 11 hepatotoxic). Severe hematological complications were anemia (4.8%), neutropenia (2.6%) and thrombocytopenia (0.9%). Anemia occurred earl), in the first 4 weeks of ART treatment. Hepatic toxicity was also seen early but continued throughout the observation period, decreasing over time. Other ADRs encountered were grade I/II toxicities of rash, peripheral neuropathy, and metabolic disturbances.
  
  
  CONCLUSIONS
  ADRs occurred frequently in patients receiving ART. Grade III/IV toxicity that required withholding or change of treatment occurred in nearly 10% of the patients. Regular clinical, and laboratory monitoring appropriate to centers with limited resources need to be devised to monitor toxicity of ART Patient education on the easily recognizable ADRs could also reduce severe drug toxicities.
authors.affiliation: Department of Internal Medicine, Faculty of Medicine, Addis Ababa University, Addis Ababa, Ethiopia.
authors.forename: Senbeta Guteta
authors.initials: SG
authors.lastname: Abdissa
authors.forename: Daniel
authors.initials: D
authors.lastname: Fekade
authors.forename: Yeweyenhareg
authors.initials: Y
authors.lastname: Feleke
authors.forename: Teshale
authors.initials: T
authors.lastname: Seboxa
authors.forename: Ermias
authors.initials: E
authors.lastname: Diro
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D044966:Anti-Retroviral Agents / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005002:Ethiopia; D005260:Female; D005500:Follow-Up Studies; D005756:Gastritis / Q000139:chemically induced; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006261:Headache / Q000139:chemically induced; D006784:Hospitals, Teaching; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents