Path: utzoo!attcan!uunet!lll-winken!brutus.cs.uiuc.edu!usc!ucla-cs!Larry.Millhofer@f140.n150.z1.fidonet.org From: Larry.Millhofer@f140.n150.z1.fidonet.org (Larry Millhofer) Newsgroups: sci.med.aids Subject: New drug approved for yeast & cryptococcus Message-ID: <31793@shemp.CS.UCLA.EDU> Date: 12 Feb 90 14:30:57 GMT Sender: news@CS.UCLA.EDU Organization: FidoNet node 1:150/140 - Black Bag BBS, Newark DE Lines: 57 Approved: aids@cs.ucla.edu Copyright: Copyright 1990, Sci.med.aids. Non-profit reproduction permitted. Copyright: All other rights reserved. Archive-number: 1721 The FDA has just approved the drug fluconazole for treatment of candidiasis (yeast infections) and cryptococcal meningitis. Its major advantages are that it can be taken orally and it is less toxic than previously available agents like amphotericin B. Full text of the FDA-Alert follows: >FDA Alert: Fluconazole Approved for AIDS-Related Fungal Infections The Food and Drug Administration approved on January 29, 1990 the drug fluconazole as an alternative treatment for two serious, AIDS-related fungal infections -- one of which is a life-threatening type of meningitis. The new drug was approved for treating cryptococcal meningitis, an inflammation of the brain and nervous system that often affects people with AIDS. The drug was also approved for treating candidiasis, a fungal infection that is most often manifested by sores in the mouth and throat, and which is estimated to afflict 80 to 90 percent of people at advanced stages of infection with the AIDS virus. Treatments already exist for these infections but their use is limited by side effects or other factors. For example, the drug amphotericin B usually is effective in treating an initial episode of cryptococcal meningitis. This conventional therapy can result in serious adverse reactions including impairment of kidney function, and suppression of bone marrow, as well as less serious side-effects such as fever and nausea. A significant proportion of treated patients relapse within a matter of months and require maintenance therapy for the rest of their lives. Lifetime treatment with fluconazole is also recommended for AIDS patients with cryptococcal meningitis who have relapsed, but these patients would likely experience fewer side-effects than those receiving chronic treatment with amphotericin B. HHS Secretary Louis W. Sullivan, M.D., said "Fluconazole offers an effective alternative treatment for people with AIDS, cancer and other diseases whose weakened immune systems make them susceptible to cryptococcal meningitis or candidiasis." HHS Assistant Secretary for Health James Mason, M.D., Dr.P.H., said fluconazole is the latest in a series of approved therapies that may help improve the quality of life for people with AIDS. Two studies comparing fluconazole to amphotericin B for cryptococcal meningitis showed that fluconazole provided comparable efficacy for the infection with fewer side effects such as kidney insufficiency. In a controlled comparison study involving AIDS patients with esophageal candidiasis, fluconazole was found to be comparable in efficacy to the drug ketoconazole. Similar results were obtained in trials comparing fluconazole with the drug clotrimazole 1n the treatment of candidiasis in people with AIDS and people with cancer. Although the drug appears to be well tolerated by most patients, it has been associated with abdominal discomfort and nausea. Less commonly, it has been associated with signs of liver damage. In rare instances, fluconazole has been linked to severe skin rashes and fatal hepatic necrosis, a form of liver failure. The drug will be marketed in both a tablet and intravenous form under the trade name Diflucan, by its manufacturer, Pfizer Inc. of New York, N.Y. -- Uucp: ...{gatech,ames,rutgers}!ncar!asuvax!stjhmc!150!140!Larry.Millhofer Internet: Larry.Millhofer@f140.n150.z1.fidonet.org