The lack of influence of food and local alcoholic brew on the blood level of Mectizan® (ivermectin)

Our findings do not support the suggestion that acute intake of alcohol is an important factor in the development of the serious adverse reactions that can occur during the treatment of patients with ivermectin (Mectizan®). Plasma levels of the drug were within the expected range and did not differ when the drug was administered with an alcoholic beverage, food, or while fasting. •Food and drink may alter the pharmacodynamics of ivermectin and contribute to serious adverse events.•We studied the effects of a local Sudanese alcoholic beverage and a food on ivermectin plasma levels.•Local food or alcoholic beverage given with ivermectin did not cause an increase in drug plasma concentrations.•These findings suggest that severe clinical problems seen with ivermectin are not associated with alcohol intake. There is concern that extraneous factors, such as food and drink, may alter the pharmacodynamics of Mectizan® (ivermectin) in patients receiving this important anti-parasitic drug, and thus might put such individuals in danger of serious adverse events. The effects of a common local alcohol-containing beverage and a local food on plasma levels of ivermectin were studied in Sudanese volunteers after administration of the standard dose used in mass drug administration programs for onchocerciasis and filariasis. Plasma levels of ivermectin at various time points (0–48h) after administration of ivermectin were ascertained by HPLC assay in ten volunteers given 150μgkg−1 ivermectin together with either a local sorghum-based food (‘assida’), or a locally brewed alcoholic beverage (‘arangi’ made from sorghum grain) or in those who were fasting. Maximum mean (±SD) plasma levels of ivermectin (67±49ngml−1) were reached within 2h in fasting patients, and had dropped to 26±20ngml−1 after 30h. The coadministration of local food or alcoholic beverage did not cause an increase in ivermectin plasma levels above those observed in people who were fasting. However, at 2h after ivermectin administration, patients given alcohol had significantly lower plasma ivermectin levels than fed patients or fasting patients. There were no significant differences among treatments for AUC0–30, Cmax, or tmax, and so the coadministration of local food or alcoholic beverage did not cause any change in pharmacokinetic parameters of ivermectin in the plasma in comparison with fasting. None of the measured levels of plasma ivermectin were greater than those reported in previous studies with this c