The Centers for Disease Control and Prevention (CDC) has received permission from the Food and Drug Administration (FDA) to provide intravenous artesunate for emergency use in the United States for persons with severe malaria.
Artesunate, a derivative from the “quing hao” or sweet wormwood plant, has been used worldwide for more than 20 years for the treatment of malaria.
HHS/FDA has not approved artesunate for marketing in this country. CDC’s investigational new drug application limits the use of artesunate to the emergency treatment of severe malaria, and the drug can be provided only through CDC.
“The introduction of artesunate marks an important improvement in the way we are able to treat those with the most severe cases of malaria,” said Paul Arguin, head of the domestic malaria unit at CDC. “Intravenous drugs are the most effective way to treat those with severe malaria. Until now, quinidine was the only IV drug that could be used and it was often not readily available in hospitals. Artesunate is considered to be more effective and has fewer side effects than quinidine, and we’re hopeful that its use will cause a decrease in the number of deaths from malaria.”
Although eliminated from the United States in 1951, malaria can still affect U.S. residents who travel or work abroad. Approximately 1,400 cases of malaria are diagnosed in this country each year; approximately 10 percent of them are cases of severe malaria. The World Health Organization (WHO) has recommended artesunate in preference to quinidine for treatment of severe malaria since 2000.
The Walter Reed Army Institute for Research (WRAIR) within the U.S. Department of Defense collaborated with HHS/CDC on the development of the artesunate protocol as an investigational new drug to expedite its availability, and will now be providing a supply of the medication to CDC. Artesunate may be used to treat malaria patients who need IV treatment because of severe disease, who have high levels of malaria parasites in the blood, who are not able to take oral medications, who do not tolerate quinidine, who may have an adverse reaction to quinidine, or in those whom quinidine treatment has proven ineffective.
The CDC Drug Service or one of the CDC Quarantine Stations located around the country will provide the drug to hospitals upon request and on an emergency basis. Physicians who receive the drug will be requested to notify CDC of any adverse event following administration of the drug. To enroll a patient with severe malaria in this treatment protocol, contact the HHS/CDC Malaria Hotline: 770-488-7788 (M-F, 8 a.m.- 4:30 p.m., Eastern Time), or after hours, call: 770-488-7100, and request to speak with a HHS/CDC Malaria Branch clinician.