Adverse ocular events on miltefosine treatment for post-kala-azar dermal leishmaniasis in India.

A 12-week course of miltefosine (MF) is recommended in India for the treatment of post-kala-azar dermal leishmaniasis (PKDL). We report a case series of four patients with PKDL, across three districts of Bihar state, who developed eye complications during treatment. They presented with acute scleritis and corneal infiltration with or without corneal ulceration. One patient solely with corneal infiltration recovered completely. The three others with corneal ulceration healed with corneal opacificity. One patient with bilateral eye involvement underwent corneal transplantation to prevent blindness. All adverse events were graded as certain using the World Health Organization-Uppsala Monitoring Centre causality assessment scale. There is need to counsel patients regarding possible adverse ocular events during MF treatment, to expand pharmacovigilance to all primary health centres in kala-azar endemic areas, and to update drug safety information considering the emerging evidence.