The WHO Advisory Committee on Safety of Medicinal Products (ACSoMP), supports the recommendations of the WHO ad-hoc Multidisciplinary Technical Group (MTG) which was set up to investigate a signal of ocular adverse events following the use of miltefosine, and provides the following advice to minimize the risks of ocular adverse events in patients exposed to miltefosine:
Information for patients
- Before starting the treatment containing miltefosine, tell your healthcare professional if you currently have any eye problem or history of eye problem as an ocular examination should be done first in these situations
- If you experience any eye discomfort during the treatment, discontinue miltefosine immediately and contact your nearest healthcare centre or a healthcare professional as soon as possible
- Please contact your nearest healthcare professional if you have any question or concern.
Information for healthcare professionals
- Before starting the miltefosine treatment the history of eye disorders should be collected and an eye examination should be done as appropriate.
- In case of current or past history of ocular disorder, the benefits and the risks of treating a patient with miltefosine should be carefully considered, and advice from an ophthalmologist should be sought where feasible.
- All patients should be informed before starting the treatment that in case of eye problems during the treatment (e.g. red eyes, increased watering, eye pain, blurred vision) they should discontinue miltefosine and contact their healthcare professional immediately.
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