FDA Approves First AIDS Drug That Prevents Blood Infection
WASHINGTON — The Food and Drug Administration approved the first drug to prevent a blood infection in people who have advanced AIDS, agency officials announced Wednesday.
The drug, rifabutin, has been on a fast track through the agency’s approval process, in part because it is for AIDS and in part because its results have been positive. Clinical tests have shown it to be effective in blocking or delaying Mycobacterium avium complex, or MAC.
“As the first product approved for the prevention of MAC disease, this drug will provide significant benefits for AIDS patients,†FDA Commissioner David A. Kessler said. “It’s a welcome addition to the growing number of products used to fight AIDS and diseases that can accompany it.â€
MAC can cause night sweats, fatigue, fever, weight loss, abdominal pain, severe anemia and liver dysfunction. The disease is caused by bacteria related to the tuberculosis germ. Researchers have said that it occurs in about a quarter of the people in the late stages of AIDS.
An advisory panel last February recommended that the FDA approve the drug. In March it was given to some patients who had AIDS.
Early studies of the drug found that it nearly halved the rate at which AIDS patients developed MAC. Clinical trials eventually were conducted on 1,100 AIDS patients, the FDA said.
The drug is manufactured by Adria Laboratories of Dublin, Ohio.
Among its side effects, rifabutin can cause rash and gastrointestinal symptoms, muscle and joint aches and discolored urine, the FDA said. It also can cause a decrease in certain white blood cells that fight infection.
