Clarithromycin (Biaxin) Formally Approved for MAC

On December 28, Abbott Laboratories announced that clarithromycin (brand name, Biaxin) had been approved for treatment of MAC (infection with Mycobacterium avium complex, also called MAI).

Clarithromycin was first approved in the U.S. for other infections in November 1991. It was in widespread use for treating MAC even before then, and has long been accepted as standard of care for this condition. The new approval should reduce the risk of insurance companies or HMOs refusing to pay for the expensive drug, using the excuse that it was not FDA-approved for this use -- and also reduce the risk of physicians inexperienced with AIDS prescribing inappropriate care.

MAC treatment today consists of either clarithromycin or azithromycin, plus at least one other drug, usually more than one. Clarithromycin should not be used alone for treating MAC, because the organisms often develop resistance to it, unless combination treatment is used.