Miltefosine is an oral anti-infective that has been used to treat several forms of leishmaniasis, including cutaneous and visceral. Post-Kala Azar Dermal Leishmanias (PKDL) commonly occurs 6 months – 1 year after apparent cure in VL patients; however it can also occur as a sequela for people who were given treatment later on during their disease process or even years after being diagnosed with PKDL.
There have been reports of ocular disorders, sometimes serious in patients treated with miltefosine for PKDL (and exceptionally VL). Reports originated mostly from India where it’s being used as a treatment option for 28 days or 12 weeks at a time . Some cases include rare instances that lead to blindness on one side and pain within their eyesight due to inflammation which has resolved following discontinuation – depending upon the severity; other than these warnings about potential injuries caused by this drug neither US FDA nor Indian regulatory agencies found any additional relevant information regarding adverse events.
The issue was discussed by the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) and a group called pharmacovigilance experts. They have been formed to further review this safety signal, which is currently insufficient data due only at least in part because some reports have shown it can cause serious side effects like internal bleeding or liver problems among other things over time; however there’s no causal connection confirmed yet between miltefosine use AND those complications just yet–so we’re recommending healthcare professionals watch out for them if their patients happen come across any stories where people took too many tablets within days/weeks.
It is important to note that PKDL or other clinical forms of leishmaniasis requiring miltefosine treatment (monotherapy), must be accompanied by a thorough ocular examination at the time of diagnosis in order for proper drug therapy.
Inform patients about the disease, its severity and how it can be treated. Also advise them to contact a doctor immediately if they experience any symptoms like pain or vision loss in order for you get diagnosed on time with an appropriate treatment plan.
Patients should contact their healthcare professional if they have questions or concerns.
Read the statement on https://www.who.int/news/item/10-02-2022-statement-on-miltefosine—potential-ocular-disorders-in-patients-treated-with-miltefosine-for-post-kala-azar-dermal-leishmaniasis-(pkdl)