title: Patterns of adverse drug reaction signals in NAFDAC Pharmacovigilance activities from September to November, 2014.
abstract: BACKGROUND
  Adverse drug reaction signals are reported information on possible causal relationships between an adverse event and a drug. The National Pharmacovigilance Centre (NPC) in Nigeria has over 3,000 reported adverse drug reaction cases which have been adequately entered into the ADR data bank.
  
  
  OBJECTIVE
  Data mining of ADR reports from September to November, 2014 were carried out in this present study with the intention to describe the pattern of ADRs and generate possible signals.
  
  
  METHODS
  A total of about 100 reported cases with arrays of adverse drug reactions were reported between September and November, 2014 and the data were analyzed using SPSS version 17.
  
  
  RESULTS
  Efavirenz/Tenofovir/Lamivudine combination was the highest reported drugs (24.2%) while efavirenz alone was reported in 8 times (8.8%) and HIV (63.3%) was the highest reported indication of drug use. Efavirenz caused central nervous system adverse reactions as revealed in the ADRs analyses. Zidovudine/Lamivudine/Nevirapine combination in concomitant use with Cotrimoxazole were reported 8 times with generalized maculopapular rashes on the trunk with some area of hyper pigmentation with intense itching documented twice and big/swollen rashes all over the faces. Zidovudine was also reported four times to cause severe anaemia.
  
  
  CONCLUSIONS
  More surveillance is advocated so as to ascertain the consistency of the observed ADRs and thereafter establish appropriate signals.
authors.affiliation: Department of Pharmacology, Therapeutics & Toxicology, College of Medicine, University of Lagos, Lagos, Nigeria.|National Agency for Food and Drug Administration and Control (NAFDAC), Abuja, Nigeria.
authors.forename: Olufunsho
authors.initials: O
authors.lastname: Awodele
authors.affiliation: National Agency for Food and Drug Administration and Control (NAFDAC), Abuja, Nigeria.
authors.forename: Ali
authors.initials: A
authors.lastname: Ibrahim
authors.affiliation: National Agency for Food and Drug Administration and Control (NAFDAC), Abuja, Nigeria.
authors.forename: Paul
authors.initials: P
authors.lastname: Orhii
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D044966:Anti-Retroviral Agents / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D057225:Data Mining; D004338:Drug Combinations; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D009549:Nigeria / Q000453:epidemiology; D060735:Pharmacovigilance; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents; D004338:Drug Combinations
keywords: ADRs; NAFDAC; Pharmacovigilance; Signals; antiretroviral agents