PMID- 35819751
OWN - NLM
STAT- MEDLINE
DCOM- 20220810
LR  - 20221012
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Print)
IS  - 0114-5916 (Linking)
VI  - 45
IP  - 8
DP  - 2022 Aug
TI  - 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.
PG  - 909-922
LID - 10.1007/s40264-022-01201-3 [doi]
AB  - 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 < 0.001) in children with pre-MDA clinical events (27.5%, 95% CI 
      25.4-29.6%) than those without (18.7%, 95% CI 17.7-19.7%). Females, older age, 
      having pre-MDA events, types of food taken before MDA and taking two or more 
      praziquantel tablets were significant predictors of AEs. CONCLUSIONS: 
      Praziquantel and albendazole MDA is safe and well-tolerated; however, one in five 
      children experience transient mild to moderate, and in few cases severe, AEs. The 
      incidence of AEs varies significantly between sex and age groups. 
      Pharmacovigilance in the MDA program is recommended for timely detection and 
      management of AEs.
CI  - (c) 2022. The Author(s).
FAU - Kabatende, Joseph
AU  - Kabatende J
AUID- ORCID: 0000-0002-3718-3213
AD  - Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska 
      Institutet, Karolinska University Hospital Huddinge, 14186, Stockholm, Sweden.
AD  - Rwanda Food and Drugs Authority, Nyarutarama Plaza, KG 9 Avenue, Kigali, Rwanda.
FAU - Barry, Abbie
AU  - Barry A
AUID- ORCID: 0000-0002-3859-3660
AD  - Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska 
      Institutet, Karolinska University Hospital Huddinge, 14186, Stockholm, Sweden.
FAU - Mugisha, Michael
AU  - Mugisha M
AD  - College of Medicine and Health Sciences, University of Rwanda, KK 737, Kigali, 
      Rwanda.
FAU - Ntirenganya, Lazare
AU  - Ntirenganya L
AD  - Rwanda Food and Drugs Authority, Nyarutarama Plaza, KG 9 Avenue, Kigali, Rwanda.
FAU - Bergman, Ulf
AU  - Bergman U
AD  - Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska 
      Institutet, Karolinska University Hospital Huddinge, 14186, Stockholm, Sweden.
FAU - Bienvenu, Emile
AU  - Bienvenu E
AUID- ORCID: 0000-0002-1555-7376
AD  - Rwanda Food and Drugs Authority, Nyarutarama Plaza, KG 9 Avenue, Kigali, Rwanda.
AD  - College of Medicine and Health Sciences, University of Rwanda, KK 737, Kigali, 
      Rwanda.
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. 
      eleni.aklillu@ki.se.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220711
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - 0 (Anthelmintics)
RN  - 0 (Soil)
RN  - 6490C9U457 (Praziquantel)
RN  - F4216019LN (Albendazole)
SB  - IM
MH  - Albendazole/adverse effects
MH  - Animals
MH  - *Anthelmintics/adverse effects
MH  - Child
MH  - Female
MH  - *Helminths
MH  - Humans
MH  - Praziquantel/adverse effects
MH  - Rwanda/epidemiology
MH  - *Schistosomiasis/drug therapy/epidemiology/prevention & control
MH  - Soil/parasitology
MH  - Watchful Waiting
PMC - PMC9360141
COIS- Joseph Kabatende, Abbie Barry, Michael Mugisha, Lazare Ntirenganya, Ulf Bergman, 
      Emile Bienvenu, and Eleni Aklillu declare no conflicts of interest.
EDAT- 2022/07/13 06:00
MHDA- 2022/08/11 06:00
PMCR- 2022/07/11
CRDT- 2022/07/12 11:35
PHST- 2022/06/06 00:00 [accepted]
PHST- 2022/07/13 06:00 [pubmed]
PHST- 2022/08/11 06:00 [medline]
PHST- 2022/07/12 11:35 [entrez]
PHST- 2022/07/11 00:00 [pmc-release]
AID - 10.1007/s40264-022-01201-3 [pii]
AID - 1201 [pii]
AID - 10.1007/s40264-022-01201-3 [doi]
PST - ppublish
SO  - Drug Saf. 2022 Aug;45(8):909-922. doi: 10.1007/s40264-022-01201-3. Epub 2022 Jul 
      11.