Current Suspected Overdose Deaths in Delaware for 2018: 259 logo

Delaware Health Alert Network #311

August 23, 2013 3:36 pm

Health Alert


This is an official

Distributed via the CDC Health Alert Network
August 23, 2013, 11:30 ET (11:30 AM ET)
HAN INFO-00354

Investigational Drug Available Directly from CDC for the Treatment of Free-Living Ameba Infections


CDC now has an expanded access investigational new drug (IND) protocol in effect with the Food and Drug Administration (FDA) to make miltefosine available directly from CDC to clinicians for treatment of free-living ameba (FLA) infections in the United States.


Infections caused by FLA are severe and life-threatening. These infections include primary amebic meningoencephalitis (PAM) caused by Naegleria fowleri* and granulomatous amebic encephalitis caused by Balamuthia mandrillaris and Acanthamoeba species.§  Although several drugs have in vitro activity against FLA, mortality from these infections remains greater than 90% despite treatment with combinations of drugs.

Miltefosine is a drug used to treat leishmaniasis and also has shown in vitro activity against FLA (1), but as an investigational drug, it has not been readily available in the United States. With CDC assistance, however, miltefosine has been administered in combination with other drugs since 2009 for FLA infections as single-patient emergency use with permission from the Food and Drug Administration. Although the number of B. mandrillaris and Acanthamoeba species infections treated with a miltefosine-containing regimen is small, it appears that a miltefosine-containing treatment regimen does offer a survival advantage for these usually fatal infections (2). Miltefosine has not been used successfully to treat a Naegleria infection, but the length of time it has taken to import miltefosine from abroad has made timely treatment of fulminant Naegleria infections with miltefosine difficult.

CDC now has an expanded access IND protocol in effect with the Food and Drug Administration to make miltefosine available directly from CDC for treatment of FLA in the United States. The expanded access IND use of miltefosine for treatment of FLA is partly supported by 26 case reports of FLA infection from around the world during the period of 2008–2012 in which miltefosine was part of the treatment regimen (Unpublished data, Division of Foodborne, Waterborne, and Environmental Diseases, National Center for Emerging and Zoonotic Infectious Diseases, CDC, 2013). Miltefosine is generally well-tolerated, with gastrointestinal symptoms as the most commonly reported adverse effects.


Clinicians who suspect they have a patient with FLA infection who could benefit from treatment with miltefosine should contact CDC to consult with an FLA expert. See the For More Information section below for information on contacting a CDC FLA expert.

For More Information


  1. Schuster FL, Guglielmo BJ, Visvesvara GS. In-vitro activity of miltefosine and voriconazole on clinical isolates of free-living amebas: Balamuthia mandrillaris, Acanthamoeba spp., and Naegleria fowleri. J Eukaryot Microbiol 2006;53:121–6.
  2. Cope JR, Roy SL, Yoder JS, Beach MJ. Improved treatment of granulomatous amebic encephalitis and other infections caused by Balamuthia mandrillaris and Acanthamoeba species [Poster]. Presented at CSTE Annual Conference, Pasadena, CA, June 9–13, 2013. Available at


* Additional information available at

Additional information available at http://

§ Additional information available at

The Centers for Disease Control and Prevention (CDC) protects people’s health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations.


You are receiving this email because you are a registered member of the Delaware Health Alert Network. If you are not a member and would like to subscribe, please register at

Download Adobe Acrobat Reader Please note: Some of the files available on this page are in Adobe PDF format which requires Adobe Acrobat Reader. A free copy of Adobe Acrobat Reader can be downloaded directly from Adobe . If you are using an assistive technology unable to read Adobe PDF, please either view the corresponding text only version (if available) or visit Adobe's Accessibility Tools page.

Categories of Health Alert messages:

  • Health Alert: Conveys the highest level of importance; warrants immediate action or attention.
  • Health Advisory: Provides important information for a specific incident or situation; may not require immediate action.
  • Health Update: Provides updated information regarding an incident or situation; unlikely to require immediate action.
NOTE: This page is for informational purposes only and dated material (e.g. temporary websites) may not be available.