Persons using assistive technology might not be able to fully access information in this file. For assistance, please send e-mail to: mmwrq@cdc.gov. Type 508 Accommodation and the title of the report in the subject line of e-mail.
Notice to Readers: New Medication for Severe Malaria Available
Under an Investigational New Drug Protocol
On June 21, 2007, CDC's Investigational New Drug Application (IND) for intravenous artesunate went into
effect. This IND allows for use of an investigational antimalarial medication (intravenous artesunate) under a protocol
entitled "Intravenous Artesunate for Treatment of Severe Malaria in the United States." Intravenous artesunate can be used
only under the provisions of this IND protocol because it is not a drug approved by the Food and Drug
Administration (FDA). Artesunate is in the class of medications known as artemisinins, which are derivatives from "quing hao," or
sweet wormwood plant (Artemisia annua). Only the CDC Drug Service and CDC Quarantine Stations will be permitted
to release the medication for use under this IND protocol.
Approximately 1,400 cases of malaria (nearly all imported) are diagnosed in the United States each
year; approximately 10% are cases of severe malaria
(1). Intravenous quinidine gluconate, principally used as
an antiarrhythmic medicine, also has antimalarial properties and is the only parenteral drug approved by FDA
for treatment of severe malaria that is available in the United States. However, quinidine has cardiotoxic effects and
has become less available in U.S. hospitals with the advent of newer antiarrhythmic drugs
(2,3). Since 2000, the World Health Organization has recommended artesunate in preference to quinidine for treatment of severe malaria,
and artesunate has been used outside the United States for many years
(4). CDC's IND protocol provides a mechanism
for investigational use of intravenous artesunate for patients with severe malaria in the United States.
Patient Eligibility for Investigational Use of Artesunate
The Walter Reed Army Institute for Research has agreed to provide a supply of intravenous artesunate to CDC
for release to hospitals in the United States under the IND protocol for treatment of patients with severe malaria. To
be eligible to receive intravenous artesunate under CDC's IND protocol, patients must have malaria and need
parenteral therapy because they are either unable to take oral medications, have high-density parasitemia (>5%), or have
severe malaria, indicated by other clinical criteria such as acute respiratory distress syndrome or severe anemia. In addition,
for these patients, one of the following must be true: 1) artesunate is available more rapidly than quinidine (if the drugs
are equally available, attending clinicians will decide which drug to use in consultation with CDC), 2) the patient
has experienced quinidine failure or intolerance, or 3) use of quinidine is contraindicated.
Dosage and Administration
Under the IND protocol, intravenous artesunate should
beadministered in 4 equal doses of 2.4 mg/kg each over a
3-day period. In parts of the world where artesunate is used regularly, intravenous administration typically is followed by
a course of oral antimalarial medication once the patient
is able to tolerate medications by mouth. Although artesunate
is a life-saving drug, it has a short half-life, and supplementary therapy is necessary to increase the likelihood
of eliminating all of the circulating parasites. This is similar to the current standard of care regimens in the United
States, in which a rapidly acting drug such as quinine
or quinidine is always coupled with a follow-on drug such as
doxycycline or clindamycin. The recommended options for follow-on drugs in this protocol are oral treatment with
atovaquone-proguanil (Malarone®), doxycycline, clindamycin, or mefloquine.
How to Obtain Investigational Artesunate
Artesunate will be provided free to hospitals, upon
request and on an emergency basis, by the CDC Drug Service or
by one of the CDC Quarantine Stations. Physicians who administer the drug to patients must notify CDC of any
adverse event after administration and comply with the IND protocol. To enroll a patient with severe malaria in this
treatment
protocol, health-care providers should telephone the CDC Malaria Hotline at 770-488-7788, Monday--Friday, 8
a.m.--4:30 p.m., Eastern time. At other times, callers should telephone 770-488-7100 and ask to speak with a CDC
Malaria Branch clinician.
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of
Health and Human Services.References to non-CDC sites on the Internet are
provided as a service to MMWR readers and do not constitute or imply
endorsement of these organizations or their programs by CDC or the U.S.
Department of Health and Human Services. CDC is not responsible for the content
of pages found at these sites. URL addresses listed in MMWR were current as of
the date of publication.
Disclaimer
All MMWR HTML versions of articles are electronic conversions from ASCII text
into HTML. This conversion may have resulted in character translation or format errors in the HTML version.
Users should not rely on this HTML document, but are referred to the electronic PDF version and/or
the original MMWR paper copy for the official text, figures, and tables.
An original paper copy of this issue can be obtained from the Superintendent of Documents,
U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800.
Contact GPO for current prices.
**Questions or messages regarding errors in formatting should be addressed to
mmwrq@cdc.gov.
