Safety Surveillance of Mass Praziquantel and Albendazole Co-Administration in School Children from Southern Ethiopia: An Active Cohort Event Monitoring

Tigist Dires Gebreyesus; Eyasu Makonnen; Tafesse Tadele; Habtamu Gashaw; Workagegnew Degefe; Heran Gerba; Birkneh Tilahun Tadesse; Parthasarathi Gurumurthy; Eleni Aklillu

doi:10.3390/jcm11216300

Safety Surveillance of Mass Praziquantel and Albendazole Co-Administration in School Children from Southern Ethiopia: An Active Cohort Event Monitoring

J Clin Med. 2022 Oct 26;11(21):6300. doi: 10.3390/jcm11216300.

Authors

Affiliations

¹ Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, 14186 Stockholm, Sweden.
² Ethiopian Food and Drug Authority, Addis Ababa P.O. Box 5681, Ethiopia.
³ Center for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University, Addis Ababa P.O. Box 9086, Ethiopia.
⁴ Departments of Pharmacology and Clinical Pharmacy, College of Health Sciences, Addis Ababa University, Addis Ababa P.O Box 9086, Ethiopia.
⁵ College of Medicine and Health Sciences, Hawassa University, Hawassa P.O. Box 1560, Ethiopia.
⁶ Pharmacovigilance and Clinical Trials, Botswana Medicines Regulatory Authority, Gaborone P.O. Box 505155, Botswana.

Abstract

Preventive chemotherapy (PC) with praziquantel and albendazole co-administration to all at-risk populations is the global intervention strategy to eliminate schistosomiasis and soil-transmitted helminth (STH) from being public health problems. Due to weak pharmacovigilance systems, safety monitoring during a mass drug administration (MDA) is lacking, especially in sub-Saharan Africa. We conducted large-scale active safety surveillance to identify the incidence, types, severity, and associated risk factors of adverse events (AEs) following praziquantel and albendazole MDA in 5848 school children (5−15 years old). Before MDA, 1484 (25.4%) children were prescreened for S. mansoni and STH infections, of whom 71.8% were infected with at least one parasite; 34.5% (512/1484) had S. mansoni and 853 (57.5%) had an STH infection. After collecting the baseline socio-demographic, clinical, and medical data, including any pre-existing clinical symptoms, participants received single dose praziquantel and albendazole MDA. Treatment-associated AEs were actively monitored on days 1 and 7 of the MDA. The events reported before and after the MDA were cross-checked and verified to identify MDA-associated AEs. The cumulative incidence of experiencing at least one type of MDA-associated AE was 13.3% (95% CI = 12.5−14.2%); 85.5%, 12.4%, and 1.8% of reported AEs were mild, moderate, and severe, respectively. The proportion of experiencing one, two, or ≥ three types of AEs was 57.7%, 34.1%, and 8.2%, respectively. The cumulative incidence of AEs in S. mansoni- and (17.0%) and STH (14.1%)-infected children was significantly higher (p < 0.001, χ2 = 15.0) than in non-infected children (8.4%). Headache, abdominal pain, vomiting, dizziness, and nausea were the most common AEs. Being female, older age, having S. mansoni or STH infection were significant predictors of MDA-associated AEs. In summary, praziquantel and albendazole co-administration is generally safe and tolerable. MDA-associated AEs are mostly mild-to-moderately severe and transient. The finding of few severe AEs and significantly high rates of AEs in helminth-infected children underscores the need to integrate pharmacovigilance in MDA programs, especially in high schistosomiasis and STH endemic areas.

Keywords: Ethiopia; STH; albendazole; cohort event monitoring; drug safety; pharmacovigilance; praziquantel; preventive chemotherapy; safety surveillance; schistosomiasis; school children.

Abstract

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