Artesunate/Amodiaquine-Induced Acute Extrapyramidal Reactions in Children and Younger Adults: Case Series Assessment

Mulugeta Russom (), Dawit Tesfai, Semere Gebregiorgis, Abdulmumini Usman, Selam Mihreteab, Iyassu Bahta, Elsa Mekonnen, Selamawit Ghebrehiwet and Gelila Abrham
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Mulugeta Russom: Eritrean Pharmacovigilance Centre, Ministry of Health
Dawit Tesfai: School of Pharmacy, Asmara College of Health Sciences
Semere Gebregiorgis: World Health Organization Country Office
Abdulmumini Usman: World Health Organization Country Office
Selam Mihreteab: National Malaria Control Program, Ministry of Health
Iyassu Bahta: National Medicines and Food Administration, Ministry of Health
Elsa Mekonnen: Eritrean Pharmacovigilance Centre, Ministry of Health
Selamawit Ghebrehiwet: Eritrean Pharmacovigilance Centre, Ministry of Health
Gelila Abrham: Tesseney Hospital

Drug Safety, 2016, vol. 39, issue 8, No 7, 763-768

Abstract: Abstract Introduction Several studies conducted in African countries reported the artesunate and amodiaquine (AS/AQ) tablet as a safe and well-tolerated anti-malarial drug in children and younger adults. The aim of this case series assessment was to assess the causal relationship between the AS/AQ tablet and extrapyramidal reactions in children and younger adults and to investigate the factor(s) predisposing to the adverse drug reactions. Methods The causal relationship of all the cases was first assessed individually using the Naranjo Probability Scale and then subjected to a case series assessment using Austin Bradford–Hill criteria. Results A total of 43 acute extrapyramidal reactions associated with the AS/AQ tablet were reported between 2012 and 16 November, 2015 to the Eritrean Pharmacovigilance Centre. The causality was found to be probable or highly probable for 33 (76.7 %) of the cases and the rest (10; 23.3 %) of the cases had a possible causal association. The extrapyramidal reactions had more or less similar clinical features in most of the cases and were characterized by abnormal involuntary contractions of muscles. The median age and body weight of the cases were 15 years and 40 kg, respectively, and 70 % of them were males. 90.7% of the reactions manifested in children and younger adults (aged

Date: 2016
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DOI: 10.1007/s40264-016-0429-6

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