Biochemical and hematological side effects of clofazimine in leprosy patients.

Gastrointestinal toxicity and red skin discoloration were the major side effects observed in leprosy patients undergoing long-term treatment with clofazimine (CFZ). Hematological and biochemical alterations have been cited among other side effects; however, their real magnitude and clinical significance at the doses currently employed in therapy have not been sufficiently documented. We therefore investigated the correlation between CFZ plasma concentration and biochemical (transaminases, bilirubins, alkaline phosphatase, gamma-glutamyltransferase, amylase, urea, creatinine, and potassium plasma levels) as well as hematological changes blood and reticulocyte counts, osmotic fragility, detection of Heinz bodies and methemoglobinemia (MHM), following in two regimes of treatment: CFZ as a single drug and CFZ as part of multidrug (MDT) therapy, in combination with dapsone and rifampicin. MHM and hemolytic anemia were detected in the MDT group only. Eosinophilia was found in patients of either group. Determination of hepatic, pancreatic and renal biochemical parameters showed rare, occasional changes of apparently no clinical significance. We conclude that CFZ is a generally well tolerated and safe drug when given as a daily dose of 50mg, which is currently used in leprosy patients.