Few data are available concerning the genotoxic effects of antimonial
salts therapy in humans. A patient suffering from visceral leishmanias
is was treated for 15 days with a cumulative dose meglumine antimoniat
e 42.5 g. Peripheral blood lymphocytes sampled before treatment, 7 day
s later, and at the end of therapy (day 15) were examined for the pres
ence of structural chromosome aberrations, sister chromatid exchanges
(SCEs), and micronuclei in binucleated cells. The treatment resulted i
n an increase of binucleated cells carrying micronuclei, with no chang
es in chromosome structural aberrations or in mean SCE frequency. On t
he basis of these observations and of experimental results reported in
the literature, we. conclude that therapy with meglumine antimoniate
apparently does not represent a mutagenic or carcinogenic risk to huma
ns.