Adverse effects of intralesional meglumine antimoniate and its influence on clinical laboratory parameters in the treatment of cutaneous leishmaniasis.

Objectives: Intralesional injection of pentavalent antimoniate is recommended by the World Health Organization for the treatment of cutaneous leishmaniasis (CL). This study aimed to evaluate the adverse effects of intralesional injection of meglumine antimoniate (Glucantime(®) ) and its influence on clinical laboratory parameters.

Methods: A total of 105 patients with suspected lesions and therapeutic features of CL diagnosed by direct smear or skin biopsy were included in this study. Intralesional injection of Glucantime(®) was administered to treat CL. Fifty-five of the 105 patients were checked for hematological features, liver and kidney function, and fasting blood sugar levels before and after treatment.

Results: The observed side effects included pain (89.5%), burning sensation (81.9%), erythema (45.7%), pruritus (28.6%), secondary infection (17.1%), nausea (11.4%), vomiting (7.6%), urticaria (5.7%), necrosis (2.9%), sporotrichoid lesions (2.9%), dizziness (1.9%), dyspnea (1.9%), and anaphylactic shock (0.9%). No statistically significant differences were found in occurrences of adverse effects according to the part of the body affected, patient sex or age group, except for pruritus, which appeared more frequently in extremities than in other parts of the body (P < 0.001), and secondary infection, which was observed more frequently in people aged >45 years (P < 0.042). All clinical parameters remained normal after treatment.

Conclusions: The occurrence of severe adverse reactions, particularly of anaphylactic shock, should be considered before treatment with Glucantime(®) is initiated. Thus, it is important that intralesional Glucantime(®) injections are administered in centers that are well equipped with appropriate resuscitation and support apparatus.