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(Last Updated On: April 16, 2023)

Public Alert No. 012/2023 – Important Safety Communication: Risk of Ocular Adverse Events with Miltefosine

April 15, 2023,

The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the public of risk of ocular adverse effects from the use of miltefosine for the treatment of Post-Kala-Azar Dermal Leishmaniasis (PKDL).

This information came as a result of investigation of a signal of ocular adverse events in patients exposed to miltefosine in South-east Asia. The investigation was conducted by WHO ad-hoc Multidisciplinary Technical Group (MTG).

Miltefosine is an oral anti-infective and one of the medicines with established efficacy in the treatment of some forms of leishmaniasis, a parasitic infection spread by the bite of infected female phlebotomine sandflies. Leishmaniasis can take different clinical forms, including cutaneous leishmaniasis, mucocutaneous leishmaniasis, and visceral leishmaniasis (VL).

PKDL is a sequela which can generally occur 6 months to several years after apparent cure of VL. 

The WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) is supporting 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.

The following advice is provided 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 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.
  • If ocular complications occur and a connection with miltefosine cannot be excluded, miltefosine should be discontinued immediately and an alternative treatment for leishmaniasis should be initiated if necessary. Since miltefosine has a very long half-life (>6 days), it is possible that ocular changes will not be reversible without treatment even after discontinuation of miltefosine. Therefore, an eye specialist should be consulted in such cases to avoid the possibility of permanent damage.
  • Suspected adverse events should be reported to local health authorities and the national pharmacovigilance programme without delay.

 Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng 

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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