{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T05:49:54Z","timestamp":1783748994561,"version":"3.55.0"},"reference-count":47,"publisher":"MDPI AG","issue":"21","license":[{"start":{"date-parts":[[2022,10,26]],"date-time":"2022-10-26T00:00:00Z","timestamp":1666742400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001713","name":"European and Developing Countries Clinical Trials Partnership (EDCTP) 2 program supported by the European Union","doi-asserted-by":"publisher","award":["CSA2016S-1618"],"award-info":[{"award-number":["CSA2016S-1618"]}],"id":[{"id":"10.13039\/501100001713","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Swedish International Development Cooperation Agency (SIDA)","award":["CSA2016S-1618"],"award-info":[{"award-number":["CSA2016S-1618"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>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\u201315 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\u201314.2%); 85.5%, 12.4%, and 1.8% of reported AEs were mild, moderate, and severe, respectively. The proportion of experiencing one, two, or \u2265 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 &lt; 0.001, \u03c72 = 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.<\/jats:p>","DOI":"10.3390\/jcm11216300","type":"journal-article","created":{"date-parts":[[2022,10,26]],"date-time":"2022-10-26T07:17:48Z","timestamp":1666768668000},"page":"6300","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Safety Surveillance of Mass Praziquantel and Albendazole Co-Administration in School Children from Southern Ethiopia: An Active Cohort Event Monitoring"],"prefix":"10.3390","volume":"11","author":[{"given":"Tigist Dires","family":"Gebreyesus","sequence":"first","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, 14186 Stockholm, Sweden"},{"name":"Ethiopian Food and Drug Authority, Addis Ababa P.O. Box 5681, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9259-5288","authenticated-orcid":false,"given":"Eyasu","family":"Makonnen","sequence":"additional","affiliation":[{"name":"Center for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University, Addis Ababa P.O. Box 9086, Ethiopia"},{"name":"Departments of Pharmacology and Clinical Pharmacy, College of Health Sciences, Addis Ababa University, Addis Ababa P.O Box 9086, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tafesse","family":"Tadele","sequence":"additional","affiliation":[{"name":"College of Medicine and Health Sciences, Hawassa University, Hawassa P.O. Box 1560, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Habtamu","family":"Gashaw","sequence":"additional","affiliation":[{"name":"Ethiopian Food and Drug Authority, Addis Ababa P.O. Box 5681, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Workagegnew","family":"Degefe","sequence":"additional","affiliation":[{"name":"Ethiopian Food and Drug Authority, Addis Ababa P.O. Box 5681, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heran","family":"Gerba","sequence":"additional","affiliation":[{"name":"Ethiopian Food and Drug Authority, Addis Ababa P.O. Box 5681, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Birkneh Tilahun","family":"Tadesse","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, 14186 Stockholm, Sweden"},{"name":"College of Medicine and Health Sciences, Hawassa University, Hawassa P.O. Box 1560, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5997-1157","authenticated-orcid":false,"given":"Parthasarathi","family":"Gurumurthy","sequence":"additional","affiliation":[{"name":"Pharmacovigilance and Clinical Trials, Botswana Medicines Regulatory Authority, Gaborone P.O. Box 505155, Botswana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9788-0790","authenticated-orcid":false,"given":"Eleni","family":"Aklillu","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, 14186 Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,10,26]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1018","DOI":"10.1056\/NEJMra064142","article-title":"Control of neglected tropical diseases","volume":"357","author":"Hotez","year":"2007","journal-title":"N. Engl. J. Med."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Ezeamama, A.E., Bustinduy, A.L., Nkwata, A.K., Martinez, L., Pabalan, N., Boivin, M.J., and King, C.H. (2018). 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