FDA recently approved this drug:
Schering's Noxafil (posaconazole) was approved with an indication for preventing fungal infections caused by certain molds and yeast-like Aspergillus and Candida fungi. The drug was approved for use in patients with weakened immune systems following bone marrow transplants and for patients with decreased white blood cell counts that makes it difficult for the body to fight infections following chemotherapy for cancer.
Posaconazole is a new molecular entity with an active substance never before approved for marketing in any form in the United States. The drug's safety and efficacy were evaluated in clinical trials consisting of 1,844 patients between 13 and 82 years old. In two randomized, controlled studies of patients who had compromised immunity and were at high risk for invasive fungal infections, those patients who received posaconazole had comparable or lower rates of invasive Aspergillus and Candida infections than those patients who received other antifungal infections.
The most common side effects in patients receiving posaconazole 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 included QTc prolongation (abnormal heart rhythm) and liver function impairment.
FDA said posaconazole must be taken with a full meal or nutritional supplement to allow adequate absorption of the drug into the body so it can take effect. Posaconazole has been shown to interact with several medications, including drugs that suppress the immune system, and these reactions may be serious.
FDA recently approved this drug: Schering's Noxafil (posaconazole) was approved with an indication for preventing fungal infections caused by certain molds and yeast-like Aspergillus and Candida fungi.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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