New Drug Added to Anti-AIDS Arsenal : Health: FDA approves fluconazole to battle two infections linked to the disease. The maker says its price is ‘forthcoming.’

The Food and Drug Administration approved a new drug Monday to treat two serious AIDS-related infections, one of them a critical and often life-threatening meningitis.

The drug fluconazole was approved to treat cryptococcal meningitis, an inflammation of the brain and nervous system that often strikes individuals with AIDS and can be fatal. Fluconazole was also approved for use against candidiasis, often known as thrush, a fungal infection that afflicts up to 90% of those in advanced stages of infection with the human immunodeficiency virus that causes AIDS. Thrush is frequently characterized by sores in the mouth and throat.

Fluconazole is the latest of several significant new therapies which have been approved by the FDA in recent months for the treatment of AIDS-related infections.

“This brings us one step farther ahead to finding a comprehensive treatment program for managing AIDS, which is the realistic ultimate goal for AIDS therapy,” said Dr. Dan Hoth, director of the Division of AIDS for the National Institute of Allergy and Infectious Diseases.

Last June, the FDA approved the use of aerosol pentamidine to prevent pneumocystis carinii pneumonia, the most life-threatening infection seen in AIDS patients. Also last June, the FDA approved ganciclovir to stave off cytomegalovirus retinitis, a disease which causes many AIDS patients to go blind. The agency also announced it would allow the widespread experimental use of another drug, r-erythropoietin, which alleviates the severe anemia which is often a serious side effect of taking the anti-viral AIDS drug AZT.

While cryptococcal meningitis is not seen as frequently in AIDS patients as pneumocystis carinii pneumonia, “it is devastating when it occurs,” said Dr. Paul Volberding, an AIDS specialist at San Francisco General Hospital. “That is why, for this infection, the drug is a substantial advance.”

Drugs to combat thrush and cryptococcal meningitis already exist, but they have toxic side effects or other disadvantages. The drug amphotericin B, which is effective in treating a first episode of cryptococcal meningitis, can impair kidney function, suppress bone marrow and cause fever and nausea. Also, it must be administered in a hospital. Many patients treated with amphotericin B suffer a relapse within several months and must return to the therapy for the rest of their lives.

While lifetime therapy is also recommended with fluconazole for those who experience a relapse of cryptococcal meningitis, the side effects are usually considerably less severe, the FDA said. They include abdominal discomfort and nausea. Infrequently, the drug causes liver damage and, in rare instances, it has been associated with severe skin rashes and fatal hetatic necrosis, a form of liver failure, the agency said.

Fluconazole can be administered in both tablet and intravenous forms, the FDA said. Thus, a patient need not be hospitalized to take it.

“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,” Health and Human Services Secretary Louis W. Sullivan said in a statement.

The drug is said to be expensive, although a spokesman for Pfizer Inc., the drug’s manufacturer, refused to discuss its cost. “A pricing decision will be forthcoming,” said Rick Honey, a company official.

Price has been a controversial and sensitive issue as new AIDS drugs have been developed. The manufacturers of AZT and aerosol pentamidine have both come under fire from AIDS activists for the high cost of their drugs, and the maker of AZT has cut its price twice since the drug’s approval in 1987.

Two studies that compared fluconazole to amphoterisan B for cryptococcal meningitis showed fluconazole to be just as effective for the infection with fewer side effects.

In a controlled comparison study involving AIDS patients with esophageal candidiasis, fluconazole was found to be just as effective as ketoconazole, one drug often used to treat it. Similar results were obtained in trials comparing fluconazole with another drug, clotrimazole, in the treatment of candidiasis in people with AIDS and people with cancer.

In addition to AIDS patients, the drug is also expected to help cancer patients, organ-transplant recipients, diabetics and patients on long-term antibiotic treatment or with in-dwelling catheters, Pfizer said.

William C. Steere Jr., president of Pfizer Pharmaceutical Products, a subsidiary of the company, said the drug “will offer an improved quality of life to many patients because it offers safety and dosing advantages as well as effectiveness.”

Meanwhile, an FDA panel began debating if AZT should be used by those with early stages of AIDS and by those who are infected but show no symptoms.

Studies have shown the drug to be effective in slowing the disease in the first group and in delaying symptoms in the latter group.