New drug approved for AIDS complications - Diflucan

FDA Consumer, April, 1990

New Drug Approved For AIDS Complications

AIDS patients and others with weakened immune systems have access to a new treatment for two serious infections, one of which is life-threatening.

FDA recently approved the drug Diflucan (fluconazole) for treating candidiasis, a fungal infection most often seen as sores in the mouth and throat, and cryptococcal meningitis, an inflammation of the brain and nervous system. Current treatments for these infections have limited use.

For example, the drug amphotericin B, marketed as Fungizone and Amphotericin B, usually is effective for an initial episode of cryptococcal meningitis but can result in serious adverse reactions, including impaired kidney function and bone marrow suppression. In addition, many patients relapse within months and must take the drug for the rest of their lives. Although lifetime treatment with Diflucan is recommended for cryptococcal meningitis in AIDS patients who have relapsed, in clinical studies Diflucan provided effectiveness comparable to Fungizone with fewer side effects.

In a study of AIDS patients with esophageal candidiasis, Diflucan was as effective as the drug Nizoral (ketoconazole). Results were similar in trials comparing Diflucan with the drug Mycelex (clotrimazole) in treating candidiasis in people with AIDS and people with cancer.

While Diflucan appears to be well tolerated by most patients, it has been associated with abdominal discomfort and nausea. Less commonly, it has been linked to signs of liver damage and, in rare instances, to severe skin rashes and liver failure.

The drug will be marketed in both a tablet and intravenous form by Pfizer Inc. of New York City.