FDA OKs Coartem tablets to treat malaria

WASHINGTON, April 8 (UPI) -- The U.S. Food and Drug Administration has approved Coartem tablets (artemether and lumefantrine) for treatment of acute, uncomplicated malaria infections.

The drug, to be administered to adults and children weighing at least approximately 11 pounds, is not approved for the treatment of severe malaria or to prevent the disease.

"Malaria is a global life-threatening disease," said Dr. Murray Lumpkin, deputy FDA commissioner for International and Special Programs. "It is encouraging to have new treatment available, particularly for children."

Severe malaria is different than acute, uncomplicated malaria in that patients with severe malaria have altered consciousness and other metabolic and end-organ complications, the federal agency said, noting such patients are not candidates for oral drugs and should be given intravenous anti-malarial therapy.

Malaria is transmitted when a person is bitten by an infected mosquito. Coartem has been shown to be effective in geographical regions with reported resistance to chloroquine, a drug that prevents and treats malaria.

Officials said symptoms of malaria include fever, chills, and flu-like illness. Left untreated, the disease can cause severe complications, including death. About 90 percent of malaria deaths occur in Sub-Saharan Africa, but the disease is also prevalent in parts of Asia and Latin America.

Coartem is made by the Novartis Pharmaceuticals Corp. of Basel, Switzerland.