Indications Removed for Ketek

On February 12, 2007, the FDA removed 2 of the 3 previously approved indications for telithromycin (Ketek; Sanofi-Aventis): acute bacterial exacerbation of chronic bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis; and acute bacterial sinusitis due to S pneumoniae, H influenzae, M catarrhalis, or Staphylococcus aureus.

Telithromycin is now indicated only for the treatment of mild-to-moderate community acquired pneumonia caused by S pneumoniae (including multidrug-resistant isolates), H influenzae, M catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae for patients aged ≥18 years.

The updated label includes a boxed warning and the statement that telithromycin is contraindicated in patients with myasthenia gravis.?Warnings were also strengthened for hepatotoxicity (liver injury), loss of consciousness, and visual disturbances.

On January 20, 2006, the FDA advised healthcare professionals and patients that the Annals of Internal Medicine had published an article (2006; 144:415–420) that described 3 patients who experienced serious liver toxicity following the administration of telithromycin. These cases were also reported to the FDA’s MedWatch.

Telithromycin is marketed and used extensively in many other countries, including European nations and Japan. For more information see:

• Ketek (Telithromycin) Label

• Medication Guide for Patients (MedGuide)

• FDA News

• Historical Information