Larry.Millhofer@f140.n150.z1.fidonet.org (Larry Millhofer) (02/12/90)
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.
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