ORIGINAL: Adverse Drug Reactions and Changes in Haematological and Clinical Chemistry to Two ACTs among Nigerian Children with Acute Uncomplicated Malaria

West African Journal of Medicine 2023 December; 40(12): 1332-1340 PMID: 38261578

Authors

  • O. E. Anjorin Department of Emergency Medicine, Obafemi Awolowo University Teaching Hospital, Ile Ife, Nigeria.
  • I. A. Anjorin Department of Family Medicine, University College Hospital, Ibadan, Nigeria.
  • C. O. Falade Department of Pharmacology and Therapeutics, University of Ibadan, Ibadan, Nigeria.

Keywords:

Adverse drug reactions, Artemisinin based combination therapy, Malaria, Nigeria

Abstract

Background: Adverse drug reaction (ADR) is a global and frequently occurring medical emergency with increased cases of mortality annually. ADRs can occur with the use of all drugs including artemisinin-based combination therapy (ACTs) which are currently the treatment of choice for acute uncomplicated malaria globally. Numerous doses of ACTs are administered daily in malaria endemic areas.

Aims: This study determined the incidence, pattern of presentation and factors associated with ADRs to two ACTs- artemisinin piperaquine (AP) and artemether-lumefantrine (AL) among children with confirmed acute uncomplicated malaria in Ibadan, Nigeria.

Methods: Children aged 2-10 years enrolled into a larger study evaluating the safety and efficacy of artemisinin /piperaquine (AP) and artemether /lumefantrine (AL) using the WHO 28-day protocol were studied. Monitoring for ADR was based on history from the parent and /or child (for occurrences of treatment emergent signs and symptoms), physical examinations and abnormalities in laboratory investigations- full blood count, blood chemistry and liver function tests. Causality assessment for the ADR was by the Naranjo algorithm scale.

Result: 108 of 114 (94.7%) children completed the study. Over half [61(56.5%] were males. The mean age of enrollees was 65.1±30.0 months. Day 28 adequate clinical and parasitological response (ACPR) for AP was 96.1% and 90.4% for AL. Observed ADRs were cough, diarrhea, loss of appetite, abdominal pain, rash, irritability, insomnia and headache. The prevalence was similar in the two treatment groups (AL=14%, AP= 11%; ρ=1.000). The incidence of ADR to both ACTs was 12/1000 patients per day. All ADRs were mild and resolved spontaneously. No notable associated factor to ADR was detected in this study.

Conclusion: Artemether-lumefantrine and Artemisinin piperaquine were found to be safe in the study population.

Published

2023-12-30

Issue

Vol. 40 No. 12 (2023): The West African Journal of Medicine

Section

Articles
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