FDA approved the drug for use in patients who have weakened immune systems following bone marrow transplants and for patients with a condition (decreased white blood cell counts) that makes it difficult for the body to fight infections following chemotherapy for cancer.

"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."

Noxafil, a new molecular entity (NME), is an antifungal drug which contains an active substance that has never before been approved for marketing in any form in the United States.

The safety and efficacy of Noxafil were evaluated in clinical trials consisting of 1,844 patients between 13 and 82 years of age. In two, randomized, controlled studies of patients who had compromised immunity and were at high risk for invasive fungal infections, those patients who received Noxafil had comparable or lower rates of invasive Aspergillus and Candida infections than those patients who received other antifungal medications.

The most common side effects in patients receiving Noxafil were nausea, vomiting, diarrhea, rash, a decrease in potassium blood levels and platelet counts, and abnormalities in liver function tests. Rare adverse events possibly related to the drug include QTc prolongation (abnormal heart rhythm) and liver function impairment.

Noxafil must be taken with a full meal or nutritional supplement (a product intended as a supplement to the diet) to allow adequate absorption of the drug into the body so it can take effect. Noxafil has been shown to interact with several medications, including drugs that suppress the immune system, and these reactions may be serious. The product label should be consulted when other drugs are prescribed with Noxafil.

Noxafil is manufactured by Schering Corporation, Kenilworth, NJ.

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They hope to identify the cause of the metallic flavor in the mouth when drinking water contains metal ions, specifically iron and copper. Their research will also evaluate the use of antioxidants to prevent the metallic flavor production. "If we can discover the cause of the production of metallic flavor, then preventive methods can be taken accordingly," Dietrich said.

In correct amounts, metals in drinking water are actually important sources of micronutrients in the human diet. In fact, iron and copper are commonly found in drinking water, and they can be an important source of these mircronutrients. However, there are thresholds. If ingested at higher concentrations, greater than three milligrams per liter, iron and copper "may cause nausea, vomiting, diarrhea, kidney and liver damage," Dietrich explained.

Some tests will be done with human volunteers to determine reactions of volatile compounds in the mouth. Since saliva contains proteins and enzymes, it may have some effect in enhancing the metallic flavor. They will also use in-vitro experiments in order to conduct experiments at higher concentrations without endangering anyone, Dietrich added.

Perception of taste and odor is very complex, and like nutritional needs, varies depending on age, gender, race, health status, prior exposure and experience.

Two graduate CEE students, Pinar Omur-Ozbek and Jose Cerrato, both of Blacksburg, Va., will work on this project.

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