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THURSDAY, March 28, 2019 (Pharmacist's Briefing) -- 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 U.S. Centers for Disease Control and Prevention says in a new guidance to health care providers.
The new guidance marks a change in U.S. treatment protocol that became necessary after the only U.S. Food and Drug Administration-approved intravenous (IV) antimalarial drug in the United States -- quinidine -- was discontinued by the maker.
Currently, artesunate is not FDA approved or commercially available in the United States, so the CDC will use a special FDA regulatory measure to ensure that IV artesunate is available for the treatment of severe malaria.
Starting April 1, health care providers must call the CDC Malaria Hotline (1-770-488-7788) 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, and a hospital representative can pick up the drug at the station. The 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 United States, according to the CDC.
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