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FDA Approves New Anti-Fungal Drug Called Noxafil

New molecular entity fights potentially fatal fungal infections in patients with weak immune systems

TUESDAY, Sept. 19 (HealthDay News) -- The U.S. Food and Drug Administration has approved the new anti-fungal drug Noxafil (posaconazole) to fight common invasive mold and fungal infections in patients with compromised immune systems.

Manufactured by the Schering Corporation, the new molecular entity, called Noxafil, contains an active ingredient that fights potentially fatal Aspergillus and Candida infections in bone marrow transplant patients or patients with otherwise low white blood counts, according to an FDA statement.

In two clinical trials involving 1,844 patients with depressed immune systems, researchers found that patients treated with Noxafil had fungal infection levels equal to or lower than patients treated with other anti-fungals, the FDA reports.

"Most healthy individuals are unaffected by these common fungi. However, individuals with severely weakened or abnormal immune systems may become seriously ill when exposed," Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement. "These infections are often fatal for this population."

Nausea, vomiting and diarrhea were side effects most often experienced by patients. More rare effects possibly linked to the drug include abnormal heart rhythm and liver problems, the FDA cautions. Patients must take Noxafil on a full stomach, with precautions against possible drug interactions.

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