Anti-Fungal Drug Gets FDA Approval

An anti-fungal drug received federal approval Monday for use in patients whose weakened immune systems make it difficult for them to fight infection.

The drug, Noxafil or posaconazole, is meant to prevent infections caused by certain molds and yeast-like funguses called Aspergillus and Candida, the Food and Drug Administration said.

Noxafil is for use in patients 13 and older who have undergone bone marrow transplants or have decreased white blood cell counts following chemotherapy, the FDA said. In such cases, those patients are vulnerable to infection.

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

Schering-Plough Corp., of Kenilworth, N.J., makes the drug.

The most common side effects of the drug include nausea, vomiting, diarrhea, rash, a decrease in potassium blood levels and platelet counts, and abnormalities in liver function tests, the FDA said. Even more rare is the possibility of the drug's causing abnormal heart rhythms and impairing proper liver function.

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Food and Drug Administration: http://www.fda.gov/