Safety Profile of Artemether-Lumefantrine: A Cohort Event Monitoring Study in Public Health Facilities in Tanzania

• Published in: Clinical drug investigation 2016-05, Vol.36 (5), p.401-411
• Main Authors: Mssusa, Alambo K., Fimbo, Adam M., Nkayamba, Alex F., Irunde, Henry F., Sillo, Hiiti B., Shewiyo, Danstan H., Hill, Geraldine, Minzi, Omary M.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Antimalarials - administration & dosage; Antimalarials - adverse effects; Artemisinins - administration & dosage; Artemisinins - adverse effects; Child; Child, Preschool; Cohort Studies; Drug Combinations; Drug Monitoring - methods; Drug Monitoring - trends; Drug-Related Side Effects and Adverse Reactions - diagnosis; Drug-Related Side Effects and Adverse Reactions - epidemiology; Ethanolamines - administration & dosage; Ethanolamines - adverse effects; Female; Fluorenes - administration & dosage; Fluorenes - adverse effects; Health Facilities - trends; Humans; Infant; Internal Medicine; Malaria - drug therapy; Malaria - epidemiology; Male; Medicine; Medicine & Public Health; Middle Aged; Nausea - chemically induced; Original Research Article; Pharmacology/Toxicology; Pharmacotherapy; Prospective Studies; Tanzania - epidemiology; Vomiting - chemically induced; Young Adult
• ISSN: 1173-2563; 1179-1918
• DOI: 10.1007/s40261-016-0385-z

Background and Objective Artemisinin combination therapies such as artemether-lumefantrine (AL) are effective for first-line treatment of uncomplicated acute Plasmodium falciparum malaria. However, the safety profile of AL in large populations has not been fully assessed. The objective of this study was to establish the safety of AL in public health facilities in Tanzania using the Cohort Event Monitoring (CEM) method. Methodology Patients who presented to public health facilities in four regions of Tanzania who were prescribed AL were enrolled in a CEM study, a prospective, observational cohort study to establish a profile of adverse events (AEs) for the medicine when used in routine clinical practice. Pre- and post-treatment forms were used to record baseline information and new health events before and 7 days after treatment. Results A total of 8040 patients were enrolled in the study, of whom 6147 were included in the analysis. Following treatment initiation, a total of 530 AEs were reported in 6 % (383) of the patients. The most frequent post-treatment AEs were in alimentary system (42 %), including vomiting, nausea, diarrhoea, abdominal pain and anorexia, followed by AEs in the neurological system (25 %). Causality assessment of the events showed that 51.9 % (275/530) were possibly related to AL. There was a significant difference in the frequency of AEs by age-group with an increase in the number of AEs as age increased ( P