Indications Cut, Black Box Added on Ketek Label

The FDA yesterday announced the removal of two indications from the labeling for the antibiotic Ketek (telithromycin), as well as the addition of a black-box warning.

Following the recommendations issued by an advisory panel in December, the FDA removed indications for acute bacterial sinusitis and acute bacterial exacerbation of chronic bronchitis from Ketek's label. The drug's sole remaining indication is for the treatment of mild to moderate community-acquired pneumonia.

The drug will now carry a black-box warning against its use in patients with myasthenia gravis, and strengthened warnings about visual disturbances, loss of consciousness, and other adverse events, in addition to the warnings about hepatotoxicity strengthened in June.