02680nas a2200265   4500000000100000008004100001260001200042653001900054653002700073653002300100653002100123653002200144100001300166700001300179700001500192700001700207700001800224700001400242245017200256856006700428300000800495490000700503520189000510022001402400       2022                            d  bMDPI AG10aDrug Discovery10aPharmaceutical Science10aMolecular Medicine10aivermectin (IVM)10aalbendazole (ALB)1 aFimbo AM1 aMinzi OM1 aMmbando BP1 aGurumurthy P1 aKamuhabwa AAR1 aAklillu E00aSafety and Tolerability of Ivermectin and Albendazole Mass Drug Administration in Lymphatic Filariasis Endemic Communities of Tanzania: A Cohort Event Monitoring Study  uhttps://www.mdpi.com/1424-8247/15/5/594/pdf?version=1652337570  a5940 v153 a<p>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 &lt; 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.</p>
  a1424-8247