PMID- 35631420
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230308
IS  - 1424-8247 (Print)
IS  - 1424-8247 (Electronic)
IS  - 1424-8247 (Linking)
VI  - 15
IP  - 5
DP  - 2022 May 12
TI  - Safety and Tolerability of Ivermectin and Albendazole Mass Drug Administration in 
      Lymphatic Filariasis Endemic Communities of Tanzania: A Cohort Event Monitoring 
      Study.
LID - 10.3390/ph15050594 [doi]
LID - 594
AB  - Ivermectin and albendazole (IA) combination preventive chemotherapy to all 
      at-risk populations is deployed to eliminate lymphatic filariasis. Although 
      safety monitoring is imperative, data from Sub-Saharan Africa is scarce. We 
      conducted a large-scale active safety surveillance of adverse events (AEs) 
      following IA mass drug administration (MDA) to identify the type, incidence, and 
      associated risk factors in Tanzania. After recording sociodemographic, clinical, 
      and medical histories, 9640 eligible residents received single-dose IA 
      combination preventive chemotherapy. Treatment-associated AEs were actively 
      monitored through house-to-house visits on day 1, day 2, and day 7 of MDA. Events 
      reported before and after MDA were cross-checked and verified to identify 
      MDA-associated AEs. 9288 participants (96.3%) completed the seven-day safety 
      follow-up, of whom 442 reported 719 MDA-associated AEs. The incidence of 
      experiencing one or more type of MDA-associated AE was 4.8% (95% CI = 4.3-5.2%); 
      this being significantly higher among those with Pre-MDA clinical events than 
      those without (8.5% versus 4.1%, p < 0.001). AEs were mild (83.8%), moderate 
      (15.9%), and severe (0.3%), and most resolved within 72 h. The incidence of 
      experiencing one, two, >/= three types of AEs were 2.8%, 1.3%, and 0.6%, 
      respectively. The most common AEs were headache (1.23%), drowsiness (1.15%), 
      fever (1.12%), and dizziness (1.06%). A chronic illness, or clinical 
      manifestation of lymphatic filariasis, or being female or pre-existing clinical 
      symptoms were independent significant predictors of AEs. IA combination 
      preventive chemotherapy is safe and tolerable, and associated AEs are 
      mild-to-moderate and transient, with few severe AEs. Safety monitoring during MDA 
      campaigns in individuals with underlying clinical conditions is recommended for 
      timely detection and management of AEs.
FAU - Fimbo, Adam M
AU  - Fimbo AM
AD  - Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska 
      Institutet, Karolinska University Hospital, 141 86 Huddinge, Stockholm, Sweden.
AD  - Tanzania Medicines and Medical Devices Authority (TMDA), Dar es Salaam P.O. Box 
      77150, Tanzania.
FAU - Minzi, Omary Mashiku
AU  - Minzi OM
AD  - Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili 
      University of Health and Allied Sciences, Dar es Salaam P.O. Box 65013, Tanzania.
FAU - Mmbando, Bruno P
AU  - Mmbando BP
AUID- ORCID: 0000-0001-7232-8708
AD  - National Institute for Medical Research, Tanga Center, Tanga P.O. Box 5004, 
      Tanzania.
FAU - Gurumurthy, Parthasarathi
AU  - Gurumurthy P
AUID- ORCID: 0000-0002-5997-1157
AD  - Pharmacovigilance and Clinical Trials, Botswana Medicines Regulatory Authority, 
      Gaborone 999106, Botswana.
FAU - Kamuhabwa, Appolinary A R
AU  - Kamuhabwa AAR
AD  - Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili 
      University of Health and Allied Sciences, Dar es Salaam P.O. Box 65013, Tanzania.
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, 141 86 Huddinge, Stockholm, Sweden.
AD  - Tanzania Medicines and Medical Devices Authority (TMDA), Dar es Salaam P.O. Box 
      77150, Tanzania.
LA  - eng
GR  - CSA2016S-1618/European &amp; Developing Countries Clinical Trials Partnership/
GR  - CSA2016S-1618/Swedish International Development Cooperation Agency/
PT  - Journal Article
DEP - 20220512
PL  - Switzerland
TA  - Pharmaceuticals (Basel)
JT  - Pharmaceuticals (Basel, Switzerland)
JID - 101238453
PMC - PMC9147720
OTO - NOTNLM
OT  - Neglected Tropical Diseases
OT  - Tanzania
OT  - active safety surveillance
OT  - albendazole
OT  - cohort event monitoring
OT  - ivermectin
OT  - lymphatic filariasis
OT  - mass drug administration
OT  - pharmacovigilance
OT  - preventive chemotherapy
COIS- The authors declare no conflict of interest.
EDAT- 2022/05/29 06:00
MHDA- 2022/05/29 06:01
PMCR- 2022/05/12
CRDT- 2022/05/28 01:38
PHST- 2022/04/12 00:00 [received]
PHST- 2022/05/09 00:00 [revised]
PHST- 2022/05/09 00:00 [accepted]
PHST- 2022/05/28 01:38 [entrez]
PHST- 2022/05/29 06:00 [pubmed]
PHST- 2022/05/29 06:01 [medline]
PHST- 2022/05/12 00:00 [pmc-release]
AID - ph15050594 [pii]
AID - pharmaceuticals-15-00594 [pii]
AID - 10.3390/ph15050594 [doi]
PST - epublish
SO  - Pharmaceuticals (Basel). 2022 May 12;15(5):594. doi: 10.3390/ph15050594.