PMID- 36362528 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230308 IS - 2077-0383 (Print) IS - 2077-0383 (Electronic) IS - 2077-0383 (Linking) VI - 11 IP - 21 DP - 2022 Oct 26 TI - Safety Surveillance of Mass Praziquantel and Albendazole Co-Administration in School Children from Southern Ethiopia: An Active Cohort Event Monitoring. LID - 10.3390/jcm11216300 [doi] LID - 6300 AB - 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, chi2 = 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. FAU - Gebreyesus, Tigist Dires AU - Gebreyesus TD AD - Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, 14186 Stockholm, Sweden. AD - Ethiopian Food and Drug Authority, Addis Ababa P.O. Box 5681, Ethiopia. FAU - Makonnen, Eyasu AU - Makonnen E AUID- ORCID: 0000-0002-9259-5288 AD - Center for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University, Addis Ababa P.O. Box 9086, Ethiopia. AD - Departments of Pharmacology and Clinical Pharmacy, College of Health Sciences, Addis Ababa University, Addis Ababa P.O Box 9086, Ethiopia. FAU - Tadele, Tafesse AU - Tadele T AD - College of Medicine and Health Sciences, Hawassa University, Hawassa P.O. Box 1560, Ethiopia. FAU - Gashaw, Habtamu AU - Gashaw H AD - Ethiopian Food and Drug Authority, Addis Ababa P.O. Box 5681, Ethiopia. FAU - Degefe, Workagegnew AU - Degefe W AD - Ethiopian Food and Drug Authority, Addis Ababa P.O. Box 5681, Ethiopia. FAU - Gerba, Heran AU - Gerba H AD - Ethiopian Food and Drug Authority, Addis Ababa P.O. Box 5681, Ethiopia. FAU - Tadesse, Birkneh Tilahun AU - Tadesse BT AD - Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, 14186 Stockholm, Sweden. AD - College of Medicine and Health Sciences, Hawassa University, Hawassa P.O. Box 1560, Ethiopia. FAU - Gurumurthy, Parthasarathi AU - Gurumurthy P AUID- ORCID: 0000-0002-5997-1157 AD - Pharmacovigilance and Clinical Trials, Botswana Medicines Regulatory Authority, Gaborone P.O. Box 505155, Botswana. FAU - Aklillu, Eleni AU - Aklillu E AUID- ORCID: 0000-0002-9788-0790 AD - Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, 14186 Stockholm, Sweden. LA - eng GR - CSA2016S-1618/European & Developing Countries Clinical Trials Partnership/ GR - CSA2016S-1618/Swedish International Development Cooperation Agency/ PT - Journal Article DEP - 20221026 PL - Switzerland TA - J Clin Med JT - Journal of clinical medicine JID - 101606588 PMC - PMC9656481 OTO - NOTNLM OT - Ethiopia OT - STH OT - albendazole OT - cohort event monitoring OT - drug safety OT - pharmacovigilance OT - praziquantel OT - preventive chemotherapy OT - safety surveillance OT - schistosomiasis OT - school children COIS- The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. EDAT- 2022/11/12 06:00 MHDA- 2022/11/12 06:01 PMCR- 2022/10/26 CRDT- 2022/11/11 01:30 PHST- 2022/09/19 00:00 [received] PHST- 2022/10/23 00:00 [revised] PHST- 2022/10/23 00:00 [accepted] PHST- 2022/11/11 01:30 [entrez] PHST- 2022/11/12 06:00 [pubmed] PHST- 2022/11/12 06:01 [medline] PHST- 2022/10/26 00:00 [pmc-release] AID - jcm11216300 [pii] AID - jcm-11-06300 [pii] AID - 10.3390/jcm11216300 [doi] PST - epublish SO - J Clin Med. 2022 Oct 26;11(21):6300. doi: 10.3390/jcm11216300.