Safety of Praziquantel and Albendazole Coadministration for the Control and Elimination of Schistosomiasis and Soil-Transmitted Helminths Among Children in Rwanda: An Active Surveillance Study
Joseph Kabatende (),
Abbie Barry (),
Michael Mugisha (),
Lazare Ntirenganya (),
Ulf Bergman (),
Emile Bienvenu () and
Eleni Aklillu ()
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Joseph Kabatende: Karolinska Institutet, Karolinska University Hospital Huddinge
Abbie Barry: Karolinska Institutet, Karolinska University Hospital Huddinge
Michael Mugisha: University of Rwanda
Lazare Ntirenganya: Rwanda Food and Drugs Authority
Ulf Bergman: Karolinska Institutet, Karolinska University Hospital Huddinge
Emile Bienvenu: Rwanda Food and Drugs Authority
Eleni Aklillu: Karolinska Institutet, Karolinska University Hospital Huddinge
Drug Safety, 2022, vol. 45, issue 8, No 8, 909-922
Abstract:
Abstract Introduction School-based preventive chemotherapy (Deworming) with praziquantel and albendazole to control and eliminate schistosomiasis and soil-transmitted helminths as public health problems is recommended by the World Health Organization (WHO). Safety monitoring during mass drug administration (MDA) is imperative but data from sub-Saharan Africa are scarce. Objective The aim of this active safety surveillance study was to identify the incidence, type, severity, and risk factors for adverse events (AEs) following mass administration of praziquantel and albendazole. Methods Overall, 8037 school children aged 5–15 years in Rwanda were enrolled. Baseline sociodemographic, medical history and any pre-existing clinical symptoms were recorded. Participants received a single dose of praziquantel and albendazole during MDA. AEs were actively monitored on days 1, 2, and 7 post MDA. Results Overall, 3196 AEs were reported by 1658 children; 91.3%, 8.4%, and 0.3% of the AEs were mild, moderate, and severe, respectively, and most resolved within 3 days. Headache (21%), dizziness or fainting (15.2 %), nausea (12.8%) and stomach pain (12.2%) were the most common AEs. The overall cumulative incidence of experiencing at least one type of AE was 20.6% (95% confidence interval [CI] 19.7–21.5%), being significantly higher (p
Date: 2022
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DOI: 10.1007/s40264-022-01201-3
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