"FDA Approves Drug Against an Infection Often Linked to AIDS"

Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.

"FDA Approves Drug Against an Infection Often Linked to AIDS"

Wall Street Journal (12/24/92), P. 11

Abstract: A drug to prevent mycobacterium avium complex disease (MAC) in AIDS patients was approved by the Food and Drug Administration. The drug, rifabutin, is the first drug approved to prevent the life-threatening disease. Chronic debilitating symptoms of MAC infection include fever, night sweats, weight loss, fatigue, abdominal pain, severe anemia, and liver dysfunction. Rifabutin is made by Adria Laboratories in Columbus, Ohio, and will be sold under the brand name Mycobutin. Patients involved in clinical trails who received rifabutin were one-third to one-half as likely to develop MAC as were patients who received a placebo. The most common side effects linked with rifabutin are rash, gastrointestinal symptoms, muscle and joint aches, and discolored urine. The only serious adverse reaction found in the trials was a decrease in certain infection-fighting white blood cells. Rifabutin was provided in February under a Treatment Investigational New Drug protocol, which enables drug developers to provide patients with access to experimental drugs for serious and life-threatening conditions that have no satisfactory treatments. The FDA's Antiviral Drug Products Advisory Committee recommended approval of rifabutin in September. Related Story: Washington Post (12/24) P. A5

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