The drug artesunate -- the World Health Organization-recommended first-line treatment for severe malaria -- will become the first-line treatment for severe malaria in the United States, the Centers for Disease Control and Prevention says in a new guidance to health care providers.
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It marks a change in U.S. treatment protocol that became necessary after the only Food and Drug Administration-approved intravenous (IV) antimalarial drug in the U.S. -- quinidine -- was discontinued by the maker and will no longer be available.
Currently, artesunate is not FDA approved or commercially available in the U.S., so the CDC will use a special FDA regulatory measure to ensure that IV artesunate is available for treatment of severe malaria.
Starting April 1, health care providers must call CDC's Malaria Hotline (770-488-7788) to obtain the IV artesunate. After a CDC expert confirms that IV artesunate is needed, the drug will be released free of charge to the CDC quarantine station closest to the requesting hospital, which can pick the drug up at the station.
CDC is stocking artesunate at 10 quarantine stations and will work with the stations and hospitals to ensure swift delivery of the drug. There will be a sufficient supply of IV artesunate for treatment of all cases of severe malaria in the U.S., according to the CDC.
In 2017, there were about 219 million cases of malaria worldwide and 435,000 deaths. Each year, an average of 1,700 travelers to countries where malaria is common return to the U.S. with malaria, and that number is on the rise. Of those, about 300 people return to the U.S. with severe malaria, the CDC said.
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