CDC is issuing new guidance to clinicians for the treatment of severe malaria cases in the United States (U.S.). This change in treatment protocol is necessary because the only FDA-approved intravenous (IV) antimalarial drug in the U.S., quinidine, has been discontinued by the manufacturer and will no longer be available. As of April 2019, artesunate, the WHO-recommended first-line treatment of severe malaria, will become the first-line treatment for severe malaria in the U.S.
Malaria has long been a major cause of illness and deaths with an estimated 219 million cases of malaria worldwide and 435,000 deaths in 2017. In the U.S., an average of 1,700 travelers to malaria-endemic countries return with malaria, and that number is increasing. Among those, about 300 persons return with severe malaria.
While at this time, artesunate is neither FDA approved nor commercially available in the United States, CDC has taken action to ensure IV artesunate is available through an expanded use investigational new drug (IND) protocol, an FDA regulatory mechanism. This IND for IV artesunate allows an effective antimalarial to be available through CDC for treatment of severe malaria in the United States. Clinical studies have shown that IV artesunate is safe, well tolerated and can be administered to infants and children, and to pregnant women in their second and third trimesters and during lactation. In the first trimester of pregnancy, the benefits of IV artesunate treatment outweigh the risk of death and poor outcomes due to severe malaria.
Starting April 1, 2019, U.S. clinicians must call CDC’s Malaria Hotline (770-488-7788) to obtain the IV artesunate. When consultation with a CDC expert determines that IV artesunate is needed, the drug will be released free of charge to the CDC quarantine station nearest to the requesting hospital. While hospitals are responsible for the pickup arrangements, CDC is stocking artesunate at 10 quarantine stations and will work with the stations and hospitals to ensure swift receipt of the treatment. CDC anticipates that there will be sufficient supply of IV artesunate for treatment of all cases of severe malaria in the U.S.
For detailed information on the criteria for IV artesunate treatment and other frequently asked questions, CDC has posted a Malaria Notice with guidance for hospitals and healthcare providers.