WEDNESDAY, April 8 (HealthDay News) -- The Novartis drug Coartem (artemether and lumefantrine) has been approved by the U.S. Food and Drug Administration to treat uncomplicated malaria in adults and children, the agency said Wednesday in a news release.

Children must weigh at least five kilograms (approximately 11 pounds) to be candidates for the drug, which isn't approved to prevent malaria or treat very serious cases.

Travelers from the United States to high-incidence areas are at risk of acquiring the mosquito-borne disease, which has warning signs including fever, chills and flu-like symptoms. Many areas with a high incidence of malaria report resistance to a standard treatment, a drug called chloroquine.

Malaria can cause death if left untreated. Up to 500 million new cases develop each year worldwide, and about 90 percent of fatal cases are reported in sub-Saharan Africa. The disease also is prevalent in Asia and Latin America, the FDA said.

Coartem should be taken with food, preferably containing fat, which aids in the body's absorption of the drug.

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